Researchers at the Bluhm Cardiovascular Institute’s Clinical Trials Unit of Northwestern conduct clinical research trials on all aspects of heart and vascular disease.
About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.
Department of Medicine Clinical Trials
The following searchable list includes all Department of Medicine clinical trials currently looking for participants.
For more information about our clinical trials, please contact Tara Scavelli at 312-926-6106.
Find information on participating in the research done through the BCVI CTU via our Frequently Asked Questions page.
Cardiovascular Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients
Description of Research Trial: To evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral regurgitation (MR) that are at high …
Description of Research Trial: To evaluate (study) the safety and effectiveness of the MitraClip System (“Study Device”) in patients with of mitral regurgitation (MR) that are at high risk for mitral valve surgery. The Study Device consists of an implantable clip to repair the mitral valve and a delivery catheter (a thin, flexible tube through which the clip is passed into the body). The Study Device has not been approved by the US Food and Drug Administration (FDA) for use outside of research trials, and is considered experimental in this study. Participant Requirements: The COAPT Trial is recruiting individuals who have moderate-to-severe or severe functional mitral regurgitation (FMR) and have been determined to be at high risk for traditional mitral valve surgery. FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. This is a randomized study which means that there is a 50/50 chance (like flipping a coin) of being assigned to receive the study device or not. Subjects assigned to the Control (no Device group) may be eligible to receive the Study Device after their two year study visit. Up to 420 patients at 75 medical centers in North America will participate in this clinical study. We hope to enroll up to 20 participants here at Northwestern. Participation in the study will last up to five years.
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowe…
The BEST-CLI study This study is recruiting participants diagnosed with peripheral artery disease (PAD) that has led to critical limb ischemia (CLI). In CLI, arteries that deliver blood to the leg and foot are narrowed or blocked by plaque buildup (atherosclerosis). CLI can cause pain in the foot or leg even when sitting or lying at rest; it also can cause foot and leg ulcerations, and can sometimes lead to gangrene and loss of the leg. CLI is usually treated by operations or procedures that increase blood flow to the leg and foot, in order to relieve these symptoms, heal the ulcers, and preserve the limb. There are two different ways to increase the blood flow in CLI. One is with open surgery, which creates a bypass around the blockage. The other is with endovascular treatment (often called angioplasty), a minimally invasive procedure that opens the blocked arteries directly. Angioplasty is performed with balloons and other tools that clear plaque, and sometimes permanent implantation of small, mesh-like metal tubes called “stents”. Both types of treatment – open surgery and angioplasty - are considered reasonable and appropriate for patients with CLI. Half of the participants in this study will have open surgery and half will have endovascular treatment. The assignment of treatment is random, meaning purely by chance (50:50, just like a coin toss). The purpose of the study is to learn about which therapy is more suitable for those patients who are candidates for both open surgery and endovascular treatment, and to provide information regarding cost effectiveness of the two different types of treatment. We expect 2100 participants to enroll from approximately 120 different study centers across the United States, Canada, and possibly other countries. We hope to enroll up to 20 participants at Northwestern.
HOme-based moNitORed exercise for PAD
This study will determine the effects of a home based walking exercise intervention on walking ability in people with peripheral artery disease (PAD).
Peripheral artery disease
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in…
Carotid revascularization for primary prevention of stroke (CREST-2) is a multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.
Genomic Response Analysis of Heart Failure Therapy in African Americans
Congestive heart failure often results in shortness of breath or fatigue with exertion. Medical treatment for this problem usually consists of medications such as Lisinopril (also called ACE inhibitors or ARBs) and Lopressor (als…
Congestive heart failure often results in shortness of breath or fatigue with exertion. Medical treatment for this problem usually consists of medications such as Lisinopril (also called ACE inhibitors or ARBs) and Lopressor (also called beta blockers). It is believed that a fixed dose combination of Isosorbide Dinitrate and Hydralazine (FDC I/H) works better in African Americans with heart failure when compared to their white counterparts. Despite the possible benefits, the drug is prescribed in only 25% of African Americans. It is believed that the positive response to this drug may be a difference in the genetic make-up of African Americans. “DNA”, “gene”, or “genetic make-up” is inherited information (a blueprint) about the structure and function of cells in the human body that make up the color of our hair and eyes and may influence the way our bodies respond to certain stimuli such as smoking, an illness, or infections. FDC I/H is FDA (Food and Drug Administration) approved for self-designated African Americans with heart failure. The goal of the current study is to see if a genetic blood test would indicate who within the African American group would show a positive response to the study medication. We are asking 500 self-designated African Americans who are 18 years old and older with congestive heart failure to participate. Up to 50 subjects will be asked to participate at Northwestern; the study duration is approximately 24 months.
SUSTAIN-IT: Sustaining quality of life of the aged: Heart transplant or mechanical support?
This study is looking for patients, 60-80 years of age, who are scheduled to receive a mechanical circulatory support (MCS) device for long-term treatment or listed with the United Network for Organ Sharing (U…
This study is looking for patients, 60-80 years of age, who are scheduled to receive a mechanical circulatory support (MCS) device for long-term treatment or listed with the United Network for Organ Sharing (UNOS) for heart transplant (HT). This study is also enrolling the caregivers of these patients. The purpose of this study is to compare the health-related quality of life (HRQOL), symptoms, thinking and adverse events between these two patient groups. This study will also evaluate the HRQOL of these patients’ caregivers. Approximately 40 patients and 40 caregivers will be enrolled in the study at Northwestern.
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to find out if the mitral valve can be safely implanted using a procedure that is simpler than the open-heart procedure being used today and may be safer for patients who are at a higher risk from convent…
The purpose of this study is to find out if the mitral valve can be safely implanted using a procedure that is simpler than the open-heart procedure being used today and may be safer for patients who are at a higher risk from conventional open-heart surgery. The new device is called the Neovasc Tiara Mitral Valve System. It includes the Neovasc Tiara Mitral Transcatheter Heart Valve and the Tiara Transapical Delivery System. The device being studied would be implanted without the need for an open-heart procedure and without the need for a heart and lung machine. This is the first research study for this device that will be carried out in a small number of subjects. This study will include 30 subjects (10 in the US, 5 in Canada, and 15 in Europe) at up to 8 sites world-wide.
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure. …
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
ACUpuncture after HEART Surgery
The purpose of this study is to see if acupuncture after heart surgery can prevent onset of atrial fibrillation (AF) and reduce pain, nausea and symptoms of depression. AF is an irregular heartbeat, which may cause symptoms such as pounding sensations in the chest, diz…
The purpose of this study is to see if acupuncture after heart surgery can prevent onset of atrial fibrillation (AF) and reduce pain, nausea and symptoms of depression. AF is an irregular heartbeat, which may cause symptoms such as pounding sensations in the chest, dizziness, fatigue, chest pain and/or shortness of breath and can cause blood clots to form in the heart. AF is one of the most common complications to occur after heart surgery. Acupuncture involves the insertion of extremely thin needles through the skin at strategic points on the body. Acupuncture has been used in traditional Chinese medicine for thousands of years for a variety of illnesses and has been shown to be effective for the treatment of nausea and vomiting in adults following surgery. Acupuncture seeks to release the flow of the body's vital energy or "chi" by stimulating points along 14 energy pathways. Scientists say the needles cause the body to release endorphins -- natural painkillers -- and may boost blood flow and change brain activity.
AdaptResponse Clinical Trial
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT in…
The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
PRevalence Of Microvascular dySfunction in Heart Failure with Preserved Ejection Fraction
The purpose of this research study is to investigate prevalence of coronary microvascular (small vessels) dysfunction in patients with heart failure with preserved fraction of outbound blood pumped from the hear…
The purpose of this research study is to investigate prevalence of coronary microvascular (small vessels) dysfunction in patients with heart failure with preserved fraction of outbound blood pumped from the heart (ejection fraction) and also to study underlying disease mechanisms related to this condition. We expect participants will be in this research study for 1 year. This study will involve up to a total of 2 visits to the study site and one phone call follow-up.
Non-invasive Detection of Right Ventricular Interstitial Fibrosis using MRI in Patients with Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ej…
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ejection fraction (HFpEF) by employing cardiac MRI-derived T1 mapping, an indicator of the degree of diffuse fibrosis, that may allow us to answer the following research questions: 1) Does T1 mapping accurately detect diffuse RV fibrosis?; 2) Do pulmonary hypertension (PH) HFpEF patients have increased RV fibrosis compared to controls and/or HFpEF patients without PH?; 3) Does the amount of RV fibrosis correlate with the degree of RV dysfunction?; 4) Does the degree of RV fibrosis vary between various etiologies of PH? Given NMHC's unique and robust HFpEF program and strength in cardiovascular MR research, Northwestern is uniquely suited for this endeavor. The ultimate goal is to provide mechanistic insight into these conditions so that effective, targeted therapies can be developed.
For more information on this study please contact us:1-855-NU-STUDY
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
This study is looking for patients who have a “leaky” tricuspid valve in the heart. The leakage of blood is also called regurgitation. The tricuspid valve is located within the right side of the heart. Th…
This study is looking for patients who have a “leaky” tricuspid valve in the heart. The leakage of blood is also called regurgitation. The tricuspid valve is located within the right side of the heart. This condition is referred to as functional tricuspid regurgitation (FTR). FTR occurs when the valve itself has been determined to be normal. However, the heart is enlarged and pulls the valve open more than it should be. As the heart works hard to pump blood throughout the body, the leaking valve allows blood to flow backwards in the wrong direction, and therefore the heart cannot pump enough blood through the body. The symptoms that patients may experience are an irregular heartbeat, fatigue, a fluttering discomfort in the neck, right abdominal pain, shortness of breath, swelling in the legs or abdomen, and cold skin. The purpose of the SCOUT study is to learn initial information about the basic safety and function of a new investigational device, the Mitralign system. The Mitralign system is a tricuspid valve repair device which uses catheters placed through two small openings in a vein in the neck to deliver surgical sutures (threads) through the ring (annulus) around the tricuspid valve. These sutures are then pulled together (as is done with threads when sewing) to make the tricuspid valve opening smaller and reduce regurgitation. These sutures are then locked in place with a small stainless steel lock. Implanting this device does not require open-heart surgery. The study valve is an investigational device meaning it has not yet been approved by the US Food and Drug Administration (FDA). This research study plans to enroll approximately 15 study participants at up to 5 sites in the US. We are looking to enroll up to 8 people at Northwestern.
SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arte…
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 2 days and 3 months following the procedure.
aMAZE Study: LAA Ligation Adjunctive to PVI for Persistent or Longstanding Persistent Atrial Fibrillation
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appe…
This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT System to percutaneously isolate and ligate the Left Atrial Appendage from the left atrium as an adjunct to planned pulmonary vein isolation (PVI) catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent atrial fibrillation. This study will be conducted in two stages: - Limited Early Stage (Stage 1): up to 175 subjects at up to 15 sites - Pivotal Stage (Stage 2): up to 600 subjects at up to 50 sites All patients from both stages will be included in the primary analysis.
A Study of CLR325 in Chronic Stable Heart Failure Patients.
The purpose of this study is to determine the safety and tolerability of CLR325 in heart failure patients to determine if further clinical development of the drug in this indication is warranted.
Inclusion Criteria: 1) Male and female patients >18 years of age. 2) Patients with a cardiac ejection fraction of ≤45% assessed within the last 6 months. 3) Patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization. 4) Systolic blood pressure 90-140 mmHg and Diastolic Blood Pressure 50-90 mmHg EXCLUSION CRITERIA: 1) Patient with known significant valvular heart disease including severe aortic stenosis or severe mitral stenosis 2) Patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days. 3) Patients who have received an intravenous infusion of a cardiac inotrope (e.g., dobutamine or milrinone) in the last 24 hours prior to randomization. 4) Patients with a pulmonary capillary wedge pressure of <10 mm Hg at baseline
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
The purpose of the GALILEO study is to assess whether a rivaroxaban-based anticoagulation strategy, following successful tran…
The purpose of the GALILEO study is to assess whether a rivaroxaban-based anticoagulation strategy, following successful trans-catheter aortic valve replacement (TAVR), compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE) and non-inferior towards primary bleeding events (PBE). Researchers are looking to find out whether rivaroxaban (“the study drug”) is effective and safe in preventing blood clots from forming in several parts of the body, such as brain, heart, legs, and also in the valve that has been implanted in the heart. Although the study drug is currently marketed for other uses, this study is considered research because it is evaluating the study drug for a use that has not yet been approved by the US Food and Drug Administration (FDA). Participation in the study will last for a minimum of 12 months and up to 24 months. We expect about 20 people here will be in this research study out of approximately 1520 people in the entire study internationally.
The Effect of KNO3 Compared to KCl on Oxygen Uptake in Heart Failure with Preserved Ejection Fraction
This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what the…
This study is enrolling participants with a diagnosis of heart failure with preserved ejection fraction (HFpEF). This is a condition that causes patients to be short of breath and limited in what they can do in their daily lives. Currently, there are no approved drugs for this condition. Researchers are trying to find new therapies for this condition. The purpose of this study is to test whether Potassium Nitrate (KNO3) will improve how people with HFpEF can exercise. In HFpEF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. We do not know exactly why these limitations occur. There is some evidence that in addition to problems with the heart, patients with HFpEF also have problems with their arteries and muscles that affect their ability to exercise. Potassium Nitrate has been shown to improve how muscles work and also improve blood flow to working muscles in the body in healthy individuals. We previously conducted a pilot study with our KNO3 pills and found them to be safe in subjects with HFpEF. We would like to now study our pills in a large study to see if we can improve exercise in HFpEF. The use of Potassium Nitrate in this study is investigational. Potassium Nitrate has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Evaluation of the Thoraflex™ Hybrid Device for Use in the Repair or Replacement of the Ascending Aorta, Aortic Arch and Descending Aorta in an Open Surgical Procedure. Protocol #: Hybrid-002
The purpose of this research study is to determine if a new investigational device, Thoraflex Hybrid, is saf…
The purpose of this research study is to determine if a new investigational device, Thoraflex Hybrid, is safe and effective for the surgical treatment of damage or disease of the aorta. The aorta is the main artery that takes blood away from the heart and runs through the chest and abdomen. The damage or disease may be due to either a bulge or ballooning in the wall of the aorta (called an aneurysm) or a tear in the wall of the aorta (called a dissection). The Thoraflex Hybrid device is used to treat both aneurysm and dissection of the aorta in the chest. Surgery for aneurysm/dissection involves replacing the weakened section of the vessel with an artificial tube, called a graft. This may be done by either, cutting out the weakened area and replacing with a graft, or by placing a graft inside the weakened blood vessel to act as a lining. The study device combines both these types of procedure in a single device. The Thoraflex Hybrid device has been licensed in Europe since 2012, but is not yet approved by the U.S. Food and Drug Administration (FDA). As the device is not yet approved by the FDA it is classed as an “Investigational” Device. This study will involve about 65-80 people at about 14 different centers in the United States. We hope to enroll up to 10 patients at Northwestern.
The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems in patients with sympto…
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems in patients with symptomatic, severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). Low operative risk means that patients may have less than a 2% chance of death 30 days after open-heart surgery. The delivery system is the Commander system, which uses transfemoral access (through a blood vessel in the leg) to place the valve in the heart. Patients agreeing to participate in this investigational (experimental) study will have a 50/50 chance of receiving the study device or surgical aortic valve replacement (SAVR). Participation in this research study will last approximately 10 years. Participants will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect no more than 120 people will be enrolled at Northwestern The study expects to enroll up to 1228 people at up to 50 sites nationally
Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF
The purpose of this study is to test if an investigational study drug, Inorganic Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of …
The purpose of this study is to test if an investigational study drug, Inorganic Sodium Nitrite Solution (AIR-001) inhaled through a nebulizer (a hand held breathing device), is safe and can improve the ability to tolerate all forms of physical activity including exercise and thus improve quality of life in people who have chronic heart failure. “Investigational” means that the study drug is currently being tested in research studies and is not approved by the US Food and Drug Administration (FDA) for standard medical use to treat heart failure. This study will consist of a minimum of three (3) study visits at the clinic and several weekly phone discussions between you and a member of the study team over the course of approximately three (3) months. During the study, participants must be able and willing to wear a special belt containing two devices that will measure activity level at all times except for bathing or swimming. This research study plans to enroll approximately 100 study participants nationwide, including approximately up to 40 people from this institution.
A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1
This study is enrolling participants with pulmona…
This study is enrolling participants with pulmonary arterial hypertension (PAH) that are currently taking at least 1 PAH drug treatment approved by the Food and Drug Administration (FDA). The drug being studied is “inhaled nitric oxide” and the device being studied is called the “INOpulse.” Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. However, inhaled nitric oxide, in combination with the INOpulse delivery device, is an investigational treatment of PAH and is not currently approved by the FDA or Health Canada. “Investigational” means that the drug-and-device combination tested in this study has not been approved by the FDA or any other health authority. The purpose of this study is to determine if inhaled nitric oxide (study drug), when given and breathed through the INOpulse (investigational device), may help treat PAH.
A Longitudinal Evaluation of Disease & Fibrosis Biomarkers in Different Groups of Heart Failure Patients to Enhance the Early Clinical Development of Compounds with Anti-fibrotic Activity in the Heart
Heart failure is the number one reason for hospitalizations in elderly adults in the US. Acute decom…
Heart failure is the number one reason for hospitalizations in elderly adults in the US. Acute decompensated heart failure (ADHF) occurs when heart failure symptoms suddenly become worse, including difficult breathing, swollen legs and feet, and fatigue. 30-50% of patients hospitalized for ADHF die or are re-hospitalized for heart failure within 6 months post discharge. Therefore, new treatment options are needed for these patients. Biomarkers are measured indicators of disease and play an important role in the discovery and development of new drugs, e.g. to treat heart failure. The purpose of this study is to gain further understanding of blood and imaging biomarkers (imaging biomarker is a feature or characteristic detectable in an image, such as a thickening of the heart wall) in different heart failure populations (stable or acutely decompensated) and to compare to subjects without heart failure. There are no experimental drugs in this study. All patients will be on standard of care treatment for heart failure. However, participants will receive an approved gadolinium-based contrast agent, called gadobutrol (Gadavist®, Gadovist®), as part of the MRI procedure. MRI contrast will be given two times during the study; Day 1 and Week 24. We expect that you will be in this research study for 1 year, which includes 3 to 4 clinical visits over 24 weeks (6 months) and a follow up phone visit at 1 year.
Understanding Outcomes with the EMBLEM™ S-ICD in Primary Prevention Patients with Low Ejection Fraction
This study is recruiting individuals that are scheduled to have Boston Scientific’s S-ICD System implanted to manage a heart condition, when it is programmed with specific settings. Since the …
This study is recruiting individuals that are scheduled to have Boston Scientific’s S-ICD System implanted to manage a heart condition, when it is programmed with specific settings. Since the entire device system is already approved by local regulatory authorities, there is nothing investigational about either the device system or the implant procedure. Specific device settings available in the approved device will be tested. The S-ICD System will be programmed to detect only very fast ventricular heart rhythms that are considered life threatening. This should allow participants to avoid receiving a shock from their device for fast heart rates that do not require a shock to terminate, and to avoid shocks that are considered inappropriate (fast signals that are not originating in the ventricle, but the device would wrongly classify as ventricular arrhythmia and deliver a shock). The follow-up visits and information collected during the conduct of the study are typical and routinely done a physician. This study provides Boston Scientific CRM with additional data about the long-term performance of the implanted device system and the optimal way to program the device to allow avoiding unnecessary and uncomfortable shocks. We expect that participants will be in this research study for up to 18 months after their S-ICD implant procedure. Participants will not need to attend any extra clinic visits for the study. Information will be recorded before and during the S-ICD implant procedure, at the time of discharge from the hospital, and thereafter during regular 6-month, 12-month, and 18-month follow-up visits that are part of standard care after an implant procedure. Approximately 1,100 participants will be enrolled in the study at up to 200 sites worldwide. We expect up to 20 people will take part here at Northwestern.
The REFLECT Trial: A Randomized Evaluation oF the TriGuard™ HDH Embolic Protection Device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation
Transcatheter aortic valve implantation (TAVI) is a procedure used to treat a disease of the aortic valve called a…
Transcatheter aortic valve implantation (TAVI) is a procedure used to treat a disease of the aortic valve called aortic stenosis, which is a narrowing of the aortic valve. One of the risks of the TAVI procedure is that particles of calcium, blood clots, atherosclerotic plaque (fatty material in blood vessel walls) or other debris (known as emboli) could break off from inside the aortic valve or blood vessels during the procedure and travel to the brain. If the embolism travels to the blood vessels that supply the brain, it could cause a stroke or other more subtle forms of brain injury with symptoms such as memory loss or diminished ability to process information. The purpose of the REFLECT study is to evaluate whether a new device, TriGuard HDH, is effective in preventing or reducing the number of these small particles or emboli from entering the blood vessels of the brain in patients undergoing TAVI as measured by an imaging study of the brain called a magnetic resonance imaging (MRI) study. Patients in this study will be randomized to one of two study groups: Treatment Group: Standard TAVI procedure with the TriGuard HDH deflection device Or Control Group: Standard TAVI procedure without the TriGuard HDH deflection device Randomization for this study is 2:1, which means patients are twice as likely to be assigned to the Treatment Group. The TriGuard HDH device is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States.
HFN - CHART
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a serie…
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a series of tests that may be completed in one visit or may be divided between two or more visits. We expect up to 20 people here will be in this research study out of approximately 200 people in the entire study nationally.
Age >40 years
HIV antibody positive
On HAART for >6 months (HIV positive cohort only)
History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in the past 6 months
Past EF <50%
Moderate or severe valve stenosis or regurgitation, or past repair or replacement
Percutaneous or surgical revascularization or active angina
Persistent atrial fibrillation
BP>160mmHg SBP or >100mmHg DBP
Comorbid inflammatory disease (e.g. RA or SLE)
Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)
Chronic use of steroids or anti-inflammatory therapy
GFR <30 mL/min
Active in a clinical trial with investigational product
Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)
Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems) For the Treatment of Moderate to Severe Mitral Regurgitation
This study is enrolling patients with moderate to severe mitral regurgitation who are considered …
This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. Mitral regurgitation, MR, is a condition in which blood flow through the mitral valve flows in the wrong direction during part of the cardiac cycle, which negatively affects the blood flow to the rest of the body. The purpose of this study is to find out if the mitral valve can be safely replaced using a procedure that is simpler than traditional open-heart procedure and may be safer for patients who are at a higher risk from open-heart surgery. The new device is called the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transseptal and Transapical Delivery Systems). The CardiAQ™ TMVI system is experimental and is not yet approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. This device is implanted without the need for an open-heart procedure and without the need for a heart and lung machine. It is implanted using a delivery catheter, which is a long tube with the valve attached at one end and a handle attached at the other end to control the placement of the valve. The long tube will be inserted through an incision inside the left or right groin (transseptal) or through an incision in the chest between the ribs (transapical). The standard medical treatments generally available to patients with mitral regurgitation who do not undergo surgery may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure mitral regurgitation. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 8 scheduled study visits after discharge from the hospital at 1, 3, 6, 12, 24, 36, 48 and 60 months after the procedure.
Patients with moderate to severe mitral regurgitation who are considered to have a high risk for traditional open-heart surgery. General Criteria:
1. Greater than or equal to 18 years of age.
2. New York Heart Associate Classification ≥ II
3. Left Ventricular Ejection Fraction ≥ 30%.
4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe) where EROA ≥ 0.30 cm2 or VC width ˃ 0.7 cm.
5. Patient is determined to be high surgical risk but operable as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist). Inclusion of a heart failure specialist is strongly recommended.
A prospective, multicenter, single-arm study designed to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)
Coronary stenting is a commonly used procedure to treat coronary artery disease. Stents have been used for many years and are an effective treatment for coronary artery disease. Some stents, called drug-eluting stents, are coated with a drug which improves the performance of the stent by reducing the risk of artery re-narrowing. be enrolled. The coronary stenting procedure that will be performed and the SYNERGY stent received are not investigational. The SYNERGY stent is made of metal and coated with the drug everolimus. Everolimus has been tested in clinical trials worldwide for use in combination with other medications to prevent heart and kidney transplant rejection. Everolimus is used as an active component on coronary stents and has been shown to prevent re-stenosis (re-narrowing) of the coronary artery in previous clinical trials. There is a coating (polymer) on the metal on the SYNERGY stent that is used to carry the drug. The polymer is located on the outside of the stent (side in contact with the coronary artery wall). Also, the polymer is bioabsorbable, which means that the majority is absorbed by the body within 3 months with complete absorption soon after. It is estimated that the everolimus drug will be released into the surrounding arterial tissue for approximately 3 months following stent implantation To help prevent blood clots that could block the opening of the stent and lead to a heart attack, participants will be required to take aspirin and one of the following medicines: clopidogrel (Plavix® ), or prasugrel (Effient® ), or ticagrelor (Brilinta® ) which are sometimes referred to as blood thinners or antiplatelet medications. The study will research the safety of aspirin plus 3 months of a second blood thinner (antiplatelet) medication [clopidogrel (Plavix), or prasugrel (Effient), or ticagrelor (Brilinta)] in people who have a SYNERGY stent. The length of time that participants may be prescribed to take one of these medications (3 months) is investigational. However, recently issued revised guidelines (2016) suggest that stopping dual antiplatelet therapy (DAPT) after 3 months may be reasonable for subjects at high risk for bleeding, following treatment with drug-eluting stents.
AdreView™ Myocardial Imaging for Risk Evaluation – A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 30%≤LVEF≤35%.
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, s…
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, some patients who receive an ICD device do not benefit from the device but rather incur the increased risks that are associated with the introduction of devices into the body. The purpose of this study is study is to evaluate if an AdreView™ heart function scan can help identify HF patients who may be more or less likely to benefit from having an ICD device implanted. Some research suggests that an ICD device may not be suitable for all patients with mild to moderate HF and a heart blood-pumping efficiency that is between 30% and 35% (ejection fraction 30-35%). An AdreView™ heart function scan could be used to identify people who have a high or low risk of a fatal event in the next 1 to 2 years. This additional information may make it possible to take a more accurate decision about who would and who would not benefit from an ICD device implantation. We expect that participants in the study will be involved for approximately 2¾ to 3 years and will need to come to clinic for study visits 8-9 times, depending upon if an ICD device is received as part of the patient's standard care or not. All participants involved in this study will receive an AdreView™ heart function scan. This heart function scan uses a radioactive imaging drug, AdreView™, which is already approved in the U.S. and Canada for diagnosing other diseases (e.g., cancers). AdreView™ is already approved in the United States by the U.S. Food and Drug Administration (FDA) for imaging the hearts of people with HF. We expect up to 25 people here will be in this research study out of approximately 2200 people in the entire study internationally.
• ≥18 years of age
• Females pre-menarchal, surgically sterile, postmenopausal, or negative pregnancy test
• Heart failure NYHA classes II or III for symptoms, ischemic or non-ischemic heart disease, eligible for ICD implantation
• Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration
• 30% ≤ LVEF ≤ 35%
• Clinically stable HF (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days
• Existing ICD or indication of ICD implantation for secondary prevention of SCD
• Hospitalized for HF or for acute coronary syndrome in the previous 40 days
• Cardiac resynchronization therapy (CRT) is planned or indicated
• Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing)
• NYHA class I or class IV symptoms
• ACC-AHA class III or class IV (unstable) angina
• Chronic renal insufficiency (serum creatinine ≥ 3 mg/dl or 265.2 μmol/L)
• Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection)
• Use of medication that could interfere with the test: e.g. amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs which inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine
• Medical condition that could interfere with the AdreView™ test (e.g. left ventricular assist device or prior heart transplant)
• Participation in a research study using ionizing radiation in the previous 12 months
Dapagliflozin EFfect on symptoms and bIomarkers iN diabetEs patients with Heart Failure (DEFINE-HF)
The purpose of this study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes. To do…
The purpose of this study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 250 people in the entire study nationally.
Exercise in Genetic Cardiovascular Conditions: Lifestyle and Exercise in Hypertrophic Cardiomyopathy: “LIVE-HCM”/ Lifestyle and Exercise in Long QT Syndrome: “LIVE-LQTS”
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants w…
This research study will look at how lifestyle and exercise impact well-being in patients with HCM or LQTS. Participants will be asked to periodically wear pedometers, upload data to a secure website, and complete interviews and questionnaires via telephone or online for up to three years. We expect up to 50 people here will be in this research study out of 4286 people in the entire study nationally.
REDO-FIRM - Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation with Focal Impulse and Rotor Modulation Guided Procedures
Patients with Atrial Fibrilation (AF) can have a fast and irregular heart rate which can cause fainting, chest pain, shortness of breath and other symptoms. T…
Patients with Atrial Fibrilation (AF) can have a fast and irregular heart rate which can cause fainting, chest pain, shortness of breath and other symptoms. This study is enrolling participants that are scheduled to undergo an electrophysiologic (EP) procedure to treat AF. This procedure looks at the heart’s electrical activity to find the area in the heart muscle that causes the heart rate to increase. It is not easy to find the site that causes AF. Therefore, multiple sites on the heart may have to be scarred (ablated). This is done to stop the fast heartbeats from spreading to other parts of the heart. The purpose of this research is to compare this standard ablation procedure to FIRM (Focal Impulse and Rotor Modulation) guided procedure. The FIRM procedure uses software and probes to find the sites of AF. Both the standard ablation and FIRM guided ablation are approved by the US Food and Drug Administration to treat arrhythmias (irregular heartbeats). We expect up to 15 people at Northwestern will be in this research study out of 268 people in the entire study internationally.
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening i…
This research study is recruiting patients who have one of the following conditions: 1. A bulge in your aortic wall (aneurysm) caused by weakening in the aortic wall. Over time, this bulge may continue to grow larger and could rupture. 2. A tear in your aortic wall (dissection). Blood flows through this tear, causing the layers of the aortic wall to separate (dissect) and create a new channel for blood flow. This channel may continue to grow and could rupture. 3. Bleeding and blood clots within your aortic wall (intramural hematoma). This can lead to weakening of the aortic wall and aortic rupture. 4. A lesion (wound) or ulcer in your aortic wall caused by aortic disease and can progress and lead to an aortic aneurysm, dissection, or rupture. 5. A traumatic injury to your aorta that can result in a tear, lesion, or rupture of the aortic wall. The aorta is the main artery in the human body that carries oxygenated blood to all parts of the body. Disease of or injury to the aorta can be a life threatening condition The study will look at treating these aortic diseases and injuries with a new medical device called the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device). Depending on the location of your aortic disease or injury, the study device will be implanted inside your aorta and one of the main arteries that branches off your aorta supply blood to the brain and arms. Study participants will be expected to return for follow-up visits with the Study Doctor at one (1), six (6), 12, 24, 36, 48, and 60 months following the procedure. This research study plans to enroll up to 435 study participants at approximately 40 sites across the country, including up to 5 people from this institution.
Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone.
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects with an Acute, Complicated Type B Aortic Dissection
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissect…
This study is recruiting patients who have an acute (very sudden onset or rapid change, within 2 weeks), complicated type B aortic dissection. One way to repair an acute, complicated type B aortic dissection is with an endovascular stent-graft. A stent-graft is a polyester fabric tube (graft) sewn onto metal springs (stent). The stent-graft is compressed inside a narrow plastic tube called a delivery system, which is inserted into the blood vessels in the groin area (femoral/iliac artery) and then threaded through the blood vessels to be placed at the area of the dissection inside the aorta. This research study will assess and evaluate safety and performance of an endovascular stent graft called the RelayPro Thoracic Stent-Graft System (the “Study Device”). The Study Device is investigational, which means it is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States. We expect that participants will be in this research study for approximately 5 years after their endovascular repair procedure. Participants will return to clinic at 1-month, 6-months, and 1-year, and then annually out to 5 years. These visits are considered part of standard care, and the results of test done at these visits will be recorded for the study. We expect up to 5 people here will be in this research study out of 80 people in the entire study nationally.
Subject must have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following:
- Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;
- Intractable pain.
Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
Subject's anatomy must meet all of the following anatomical criteria:
a. Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery.
i. Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.
b. The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
c. The proximal attachment zone should be: i. 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent). ii. 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent). iii. Proximal to non-dissected segment (healthy zone). d. The distal attachment zone should be 20 mm for all RelayPro grafts. e. Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.
5. Proximal attachment zone containing a straight segment (non-tapered, non-reverse-tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
6. Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac artery) must be in the range that can be safely treated with the RelayPro Thoracic Stent-Grafts.
7. Adequate iliac or femoral artery access for introduction of the RelayPro Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
8. Subject willing to comply with the follow-up evaluation schedule. 9. Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment.
Subjects will be excluded from the study if any of the following apply:
Diagnosis of traumatic injury or transection of the descending thoracic aorta.
Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization.
Prior endovascular or surgical repair in the descending thoracic aorta. The device may not be placed within any prior endovascular or surgical graft.
Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta, requiring repair. Dissection extension into the abdominal aorta is acceptable.
Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
Major surgical or medical procedure within 30 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within 30 days post implantation. This excludes any planned procedures for the prospective stent-graft placement.
Untreatable allergy or sensitivity to contrast media or device components, including metal stents.
Known or suspected connective tissue disorder.
Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
Coronary artery disease with unstable angina.
Severe congestive heart failure (New York Heart Association functional class IV).
Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment date.
Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
Active systemic infection and/or mycotic aneurysms.
Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation).
Less than two-year life expectancy.
Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
Currently pregnant or planning to become pregnant during the course of the study.
Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart …
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. If you agree to participate in this study, the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) and delivery system will be used to replace your failing bioprosthetic aortic valve. The delivery systems are the Commander system (transfemoral access – through the leg) and the Certitude system (transapical and transaortic access through the heart, when a small incision is made in your chest). The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) or any other governmental agency in North America for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. If you agree to participate in this research study and pass the screening tests, your involvement will last approximately 10 years. You will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
NYHA Functional Class ≥ II.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
Failing valve is unstable, rocking, or not structurally intact.
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
Performance of Kardia / Apple Watch in Detecting and Quantifying Atrial Fibrillation
This study is enrolling patients diagnosed with atrial fibrillation (AF) who have an insertable cardiac monitor (ICM) implanted to monitor their heart rhythm.The purpose of the research is to compare the accuracy of …
This study is enrolling patients diagnosed with atrial fibrillation (AF) who have an insertable cardiac monitor (ICM) implanted to monitor their heart rhythm.The purpose of the research is to compare the accuracy of the the Kardia / Apple Watch system to an insertable cardiac monitor for the detection of atrial fibrillation. AF is the most common abnormal heart rhythm and is associated with an increased risk of stroke, heart failure, and death. AF can be difficult to diagnose and manage because it can occur sporadically and cause no symptoms. In order to monitor peoples’ heart rhythm for an extended period of time, a rhythm monitor (i.e., ICM) can be implanted under the skin. These devices transmit daily to a physicians office for review. This is an accurate method but it requires an invasive procedure and it can be costly. A wearable, long-term atrial fibrillation monitor such as the Kardia band/ Apple Watch system could provide a low-cost, non-invasive method for detecting atrial fibrillation. This could help diagnose why someone had a stroke, when patients with atrial fibrillation should take blood thinners, or how patients are doing after a procedure to treat atrial fibrillation. Participation in the study lasts for 60 days and participants will be provided a Kardia band and Apple Watch to wear.
EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH TYPE 2 DIABETES OR PRE-DIABETES, AND PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inabil…
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..
Documented type 2 diabetes for at least 3 months, or prediabetes. Those with type 2 diabetes must be prescribed a lifestyle intervention alone or in combination with a stable dose(s) of at least one glucose-lowering medication during the 8 weeks prior to the screening visit.
Hemoglobin A1c inclusion criteria as follows: i. Hemoglobin A1c of 6-11% (inclusive) for patients with documented type 2 diabetes receiving metformin monotherapy; ii. Hemoglobin A1c of 6.5-11% (inclusive) for patients with documented type 2 diabetes receiving any type of glucose-lowering medication (except metformin monotherapy); iii. Hemoglobin A1c of 6.0-6.9% (inclusive) for patients with documented type 2 diabetes receiving lifestyle intervention alone; iv. Hemoglobin A1c of > 5.7% and < 6.5 % for patients with pre-diabetes
Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection fraction (EF) ≥ 45% as determined on imaging study within 18 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
Elevated NT-proBNP ≥ 300 pg/ml or BNP ≥ 100 pg/ml. For patients with permanent atrial fibrillation inclusion thresholds will be BNP ≥ 125 pg/mL or NTproBNP ≥ 500 pg/mL
Stable medical therapy for heart failure for 30 days
On a diuretic ≥30 days prior to screening visit and a stable diuretic therapy for 14 days
At least one of the following: i. Hospitalization for decompensated HF in the last 12 months; ii. Acute treatment for HF with intravenous loop diuretic or hemofiltration in the last 12 months; iii. Mean pulmonary capillary wedge pressure ≥15 mmHg or LV end diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest, or pulmonary capillary wedge pressure or LVEDP ≥25 mmHg documented during catheterization with exercise; iv. Structural heart disease evidenced by at least one of the following echo findings (any local measurement made within the 18 months prior to screening visit): 1) left atrial (LA) enlargement defined by at least one of the following: LA width ≥3.8cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55mL or LA volume index ≥29 mL/m2 2) OR left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.
Decompensated heart failure (hospitalization for heart failure within the 30 days prior to screening)
History of type 1 diabetes
History of diabetic ketoacidosis
Hemoglobin A1c <5.7 or >11% at the screening visit
Estimated glomerular filtration rate (eGFR) < 30 at the screening visit
Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 60 days prior to the screening visit.
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or transcatheter aortic valve replacement) or CRT within the 90 days after the screening visit.
Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within 30 days of the screening visit.
History of hypersensitivity to dapagliflozin
For women of child-bearing potential: Current or planned pregnancy or currently lactating.
Life expectancy <1 year at the screening visit
Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
BNP <100 pg/mL and NTproBNP<300 pg/mL at the screening visit. For patients with permanent atrial fibrillation exclusion thresholds will be BNP<125 pg/mL and NTproBNP<500pg/mL.
Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 12 weeks prior to the screening visit.
Average supine systolic BP <100 mmHg at the screening or randomization visit
Past or current history of bladder cancer
Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned donations during the study period
Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
Heart failure due to severe aortic or mitral regurgitation
Severe COPD thought to contribute to dyspnea
Isolated right heart failure due to pulmonary disease
Active and significant ischemia thought to contribute to dyspnea
Documentation of previous EF < 40% at any time
Complex congenital heart disease
Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit
Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
Bariatric surgery within the past 6 months or planned bariatric surgery within the study time course.
CardioMems device implantation within previous 4 weeks or planned CardioMems implantation during study period
For echo substudy only: history of poor echo windows as judged by the investigator
For echo substudy only: patients with ventricular paced rhythm or left bundle branch block on the most recent clinically available 12-lead electrocardiogram.
For echo substudy only: permanent atrial fibrillation
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the h…
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the investigational (not yet approved by the FDA for use in the US) Amulet device is safe and effective when compared to an FDA-approved device called the WATCHMAN LAA closure device. We expect up to 25 people here will be in this research study out of 1700 people in the entire study internationally. Participants will be involved in this research study for up to 5 years. After the procedure, participants will be asked to come to clinic for 5 in-person study visits, and will be contacted via telephone by the study team 5 times.
18 years of age or older
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6)
Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation
Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
Indicated for chronic P2Y12 platelet therapy inhibitor
Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
Implanted with a mechanical valve prosthesis
Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
Myocardial infarction (MI) within 90 days prior to randomization
New York Heart Association Class IV Congestive Heart Failure
Left ventricular ejection Fraction (LVEF) <30%
Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis
Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
History of idiopathic or recurrent venous thromboembolism
Left atrial appendage is obliterated or surgically ligated
Resting heart rate >110 bpm
Thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e. anemia as determined by the investigator which would require transfusion)
Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
CardioMEMS HF System Post Approval Study
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a metho…
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a method to measure pulmonary artery (PA) pressures by using a small wireless sensor (about the size of a paperclip) implanted into the pulmonary artery (a vessel close to your heart). Once implanted, the sensor communicates through radio frequency to an antenna contained in a pillow connected to an electronic unit and then transmits this valuable information to a secure website for your doctor to review. You will be able to take these PA pressure measurements yourself at home. In addition to these home readings, your PA pressures can also be obtained in the physician’s office, clinic, or hospital. Your doctor can access the secure website to view your measurements allowing him/her to make earlier treatment changes (usually changes in medications) to manage your heart failure remotely. The CardioMEMS HF System was approved by the US Food and Drug Administration (FDA) for commercial use, and is not considered experimental. We expect up to 180 people here will be in this research study out of 1200 people in the entire study nationally. If you agree to participate, we expect that you will be in this research study for two (2) years
Diagnosis of NYHA class III heart failure
At least 1 heart failure hospitalization within previous 12 months
Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Inability to tolerate a right heart catheterization
A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Cardiac resynchronization device (CRT) implanted within previous 3 months
Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Congenital heart disease or mechanical right heart valve
Likely to undergo heart transplantation or VAD within the next 6 months
Known coagulation disorders
Hypersensitivity or allergy to aspirin, and/or clopidogrel
Evaluation of the Safety and Performance of The Twelve Intrepid™ Transcatheter Mitral Valve Replacement System in High Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid™ TMVR Pilot Study
The research project is testing a new treatment for mitral regurgitation. The…
The research project is testing a new treatment for mitral regurgitation. The new treatment is a mitral valve replacement with a new investigational device called the Twelve Transcatheter Mitral Valve Replacement (TVMR) System. This research study is an early feasibility study, which is done to study a device that has not been used in many people. Mitral valve regurgitation (MR) occurs when the two leaflets of the mitral valve do not close correctly and blood leaks backward with each heartbeat. If left untreated, there is a risk that the heart may begin to fail and patients may have symptoms such as shortness of breath or tiredness. One treatment for MR is open-heart surgery to replace a leaky mitral valve with an artificial heart valve. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open and requires heart-lung bypass support and the heart is temporarily stopped to sew in the valve. The TMVR device is intended to be placed through a less invasive procedure, without sewing, and without requiring heart-lung bypass support and stopping the heart.
REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA: 1. Chronic symptomatic heart failure (HF) documented by the following:
a. Symptoms of HF requiring current treatment with diuretics for ≥ 30 days
b. New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
c. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months.
3. Age ≥ 40 years old
4. Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,
without documented ejection fraction <30% in the 5 years prior to study entry.
5. Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP)
a. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than
RAP by ≥ 5 mm Hg. OR
b. End-expiratory resting PCWP >15mm Hg, and greater than RAP by ≥ 5 mm Hg.
6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
a. LA diameter > 4 cm; or
b. Diastolic LA volume > 50, LA volume index > 28 ml/m2 or c. Lateral e’ < 10 cm/s; or
d. Septal e’ < 8 cm/s; or
e. Lateral E/e’ > 10 ; or f. Septal E/e’ > 15
7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
8. Subject is willing to comply with clinical investigation procedures and agrees to return for all
required follow-up visits, tests, and exams
9. Trans-septal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator. EXCLUSION CRITERIA 1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
2. Cardiac resynchronization therapy initiated within the past 6 months
3. Advanced heart failure defined as one or more of the below:
a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
b. Cardiac index < 2.0 L/min/m2
c. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months d. Patient is on the cardiac transplant waiting list
4. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
5. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain.
6. Unwilling or unable (per PhysIQ protocol) to wear tele-monitoring patch.
7. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
9. Known clinically significant untreated carotid artery stenosis likely to require intervention.
10. Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
a. Mitral valve disease defined as grade ≥ 3+ MR or > mild MS
b. Tricuspid valve regurgitation defined as grade ≥ 2+ TR;
c. Aortic valve disease defined as ≥ 2+ AR or > moderate AS
11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue);
or has a documented coagulopathy
13. Atrial fibrillation with resting HR > 100 BPM
14. Resting arterial oxygen saturation < 95% on room air
15. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
16. Right ventricular dysfunction, assessed by the site cardiologist and defined as a. More than mild RV dysfunction as estimated by TTE; OR
b. TAPSE < 1.4 cm; OR
c. RV size ≥ LV size as estimated by TTE; OR
d. Ultrasound or clinical evidence of congestive hepatopathy; OR
e. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
17. Resting RAP > 14 mmHg
18. Evidence of significant pulmonary hypertension defined as PVR > 4 Wood units
19. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
20. Hemoglobin <10 g/dl
21. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
22. Life expectancy less than 12 months for known non-cardiovascular reasons
23. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
24. Known or suspected allergy to nickel
25. Fertile women
26. Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
27. Systolic blood pressure >170 mm Hg.
28. Subjects with existing atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
29. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
30. Severe obstructive sleep apnea not treated with CPAP or other measures
31. Severe depression and/or anxiety
32. In the opinion of the investigator, the subject is not an appropriate candidate for the study
Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by…
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMANTM Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMANTM Device itself and the implantation procedure are the same as the FDA approved WATCHMANTM. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMANTM Device in this study is considered “investigational” because the WATCHMANTM Device has not been approved by the FDA for use without short-term OAC therapy. If you agree to participate in this study, we expect that you will be in this research study for about 5 years. During this time, you will be asked to come to clinic for 6-7 study visits, and the study team will contact you by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
The subject is of legal age to participate in the study per the laws of their respective geography.
The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
The subject has a calculated CHA2DS2-VASc score of 2 or greater.
The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
The subject is able and willing to return for required follow-up visits and examinations.
The subject is unable or unwilling to return for required follow-up visits and examinations.
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
The subject has a history of atrial septal repair or has an ASD/PFO device.
The subject has an implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
The subject has a life expectancy of less than two years.
The subject has a known or suspected hypercoagulable state.
A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetics and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure and preserved ejection fraction
This study is recruiting patients who have heart failure with normal ejection fraction (a measurement of the percentage of blood leaving the heart each time it pumps). The purpose of this study is to look at the efficacy and safety of the “Study Drug” neladenoson bialanate (BAY 1067197), and to learn more about how the body processes it. The study is considered research, because the Study Drug is under development and has not been approved by the US Food and Drug Administration (FDA) for use outside of a clinical study setting. Participants will be assigned at random (by chance) by a computer to receive one of five different doses of the Study Drug (5, 10, 20, 30, or 40 mg) or a placebo (a pill that looks like the Study Drug but has no active ingredient in it). There is a 3 in 4 chance of receiving some dose of the Study Drug and a 1 in 4 chance of receiving placebo. Participants will need to take the study tablets as the study doctor instructs and record doses in a diary. Additionally, at start of the study, and during the 1st, 8th, and 19th week of the treatment period, participants’ heart activity will be recorded for seven days using a device called AVIVO. A patch will be placed on the chest and connected wirelessly to a mobile device (size of a cell phone) that must be carried. The patch is waterproof and therefore it is possible to take a shower while wearing it. Taking a bath or swimming is not allowed because the patch can’t be submerged in water. After each period of 7 days the patch is to be removed and both the patch and the mobile device must be returned at the next study visit. Participation in the study will last approximately 27 weeks. Participants will be asked to attend 7 study visits to clinic and receive 3 telephone “visits” from the study team. We expect about 5 people here will be in this research study out of 288 people in the entire study internationally.
Men or women aged 45 years and older
Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP
Acute decompensated heart failure within the past 4 weeks
Inability to exercise
Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF < 40%)
Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A prospective, multicenter, randomized, controlled pivotal trial to assess transcatheter mitral valve repair with Edwards Cardioband System and guideline directed medical therapy (GDMT) compared to GDMT alone in patients with functional mitral regurgitation (FMR) and heart failure.
This study is enrolling patients with moderate-to-severe or severe functional mitral regurgitation (FMR). FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. This can lead to shortness of breath and make the heart weaker because it cannot pump enough blood for the body’s needs. The purpose of this study is to evaluate a new device to treat patients who might benefit from repair of their mitral heart valve due to functional mitral regurgitation. The device is called the Edwards Cardioband System (“Edwards Cardioband System”). The device is investigational, which means it is not yet approved by the U.S. FDA for sale in the United States. This device is placed without the need for an open-heart procedure and without the need for a heart and lung machine. Instead, the device is delivered using a less invasive approach where the Cardioband System is inserted through a vein in the groin and threaded to the heart using a delivery catheter (small plastic tube). For this study patients will be “randomized” or assigned by chance to one of two study groups: Device group or the Control group. Patients will be randomized 2:1, which means each patient has a 2 to 1 chance of being assigned to the Device group (twice as likely to be in the Device group as the Control group). Subjects assigned to the Control Group may be eligible to receive the Study Device after their 1 year study visit. Participation in this study will last for approximately 5 years. Both Device and Control Group participants will be asked to return for visits at 1 month, 6 months, and 1, 2, 3, 4 and 5 years. This study is being conducted in up to fifty (50) hospitals in the United States, Canada, and/or Europe and plans to enroll up to 525 participants, including approximately 10 people from this institution
Inclusion: 1. Functional MR (≥ 3+ by echo); 2. Patient hospitalized due to heart failure during 12 months prior to enrollment OR BNP >400 pg/ml or NT‐BNP>1500 pg/ml; 3. LVEF > 20% and LVEDD ≤ 70mm 4. NYHA Class II‐IVa heart failure symptoms despite medical therapy Exclusion: 1. Degenerative MR including mixed degenerative/functional MR; 2. Severe mitral annular calcification; 3. Hypertrophic cardiomyopathy; 4. Severe tricuspid regurgitation;