Clinical Trials
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.
Contact Us
For more information about our clinical trials, please contact Anna Huskin at 312-695-4067.
Participant Information
Find information on participating in the research done through the BCVI CTU via our Frequently Asked Questions page.
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COAPT 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… 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. For more information on this study please contact us: Brady, Caitlin |
BEST-CLI 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… 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. For more information on this study please contact us: Toaspern, Lillian |
CREST-2 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 randomiz… 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. For more information on this study please contact us: Toaspern, Lillian |
GRAHF-2 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 combin… 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. For more information on this study please contact us: Mkrdichian, Hamorabi |
SUSTAIN-IT 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 t… 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. For more information on this study please contact us: Zinn, Sarah |
MOMENTUM 3 (HeartMate 3)
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.
Primary Inclusion:
Primary Exclusion:
NCT02892955 STU00200932 For more information on this study please contact us: Dreisbach, Alexander |
AdaptResponse 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 n… 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). For more information on this study please contact us: Carswell, Amy |
aMAZE Study 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 ab… 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.
For more information on this study please contact us: Carswell, Amy |
CLR-325 CLR325X2202: The purpose of the study is to determine if an investigational drug called CLR325 (“the study drug”) is safe and tolerable in heart failure patients. “Investigational” means the study drug has not been approved the FDA for the treatment of people with heart failure. The … CLR325X2202: The purpose of the study is to determine if an investigational drug called CLR325 (“the study drug”) is safe and tolerable in heart failure patients. “Investigational” means the study drug has not been approved the FDA for the treatment of people with heart failure. The study drug is currently not “on the market” (available for prescription for and/or to buy) in any country. This is the first time it will be studied in patients with heart failure.
Participants will receive a single infusion of either the study drug or a single infusion of placebo. A placebo is a dummy drug with no active medicine inside and is used to make sure that the changes reported are not just happening by chance. The placebo used will be a saline (salt water) solution.
Study participation will last for about 1 month. During this time participants will be asked to come to the hospital once and the outpatient clinic 3 times.
We expect to enroll up to 8 people here out of 40 people in the entire study nationally. 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. 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.
NCT02696967 STU00202187 For more information on this study please contact us: Roshevsky, Daniel Scott |
KNO3CK OUT HFPEF KNO3CK-OUT HFpEF: 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 dru… KNO3CK-OUT HFpEF: 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. For more information on this study please contact us: Patel, Harnish H |
PARTNER 3 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 replace… 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 For more information on this study please contact us: Warzecha, Anna |
Tafamidis Extension This is a study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects, diagnosed with thransthyretin cardiomyopathy (ATTR-CM), with tafamidis for up to 60 months, … This is a study designed to obtain additional safety data for tafamidis meglumine 20 mg and 80 mg (or tafamidis 61 mg where available), and to continue to provide enrolled subjects, diagnosed with thransthyretin cardiomyopathy (ATTR-CM), with tafamidis for up to 60 months, or until subject has access to tafamidis for ATTR-CM via prescription, whichever occurs first.
NCT02791230 STU00202870 For more information on this study please contact us: Gold, Sheano G |
REFLECT 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 … 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. For more information on this study please contact us: Duquette, Audrey |
ADAPTABLE Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin ever… Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE). The goal of ADAPTABLE is to try to find out which dose of aspirin is better for subjects who have heart disease. Subjects who join this study will take either low-dose or regular aspirin every day. That way, we can learn which is better in terms of reducing the risk of heart attacks, strokes,
bleeding, and death. We expect up to 15,000 subjects with heart disease from across the U.S. will take part in ADAPTABLE. Criteria Inclusion Criteria: • Known atherosclerotic cardiovascular disease (ASCVD), defined by a history of prior myocardial infarction, prior coronary angiography showing ≥75% stenosis of at least one epicardial coronary vessel, or prior coronary revascularization procedures (either PCI or CABG), or history of chronic heart disease, CAD, ASCVD • Age ≥ 18 years • No known safety concerns or side effects considered to be related to aspirin, including • No history of significant allergy to aspirin such as anaphylaxis, urticaria, or significant gastrointestinal intolerances • No history of significant GI bleed within the past 12 months • Significant bleeding disorders that preclude the use of aspirin • Access to the Internet. In the event that the CDRNs are notified that a cohort of patients without internet access can be included, then patient agreement will be obtained during the consent process to provide follow-up information by telephone contact with the DCRI Call Center. • Not currently treated with an oral anticoagulant - either warfarin or a novel anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) - and not planned to be treated in the future with an oral anticoagulant for existing indications such as atrial fibrillation, deep venous thrombosis, or pulmonary embolism. • Not currently treated with ticagrelor and not planned to be treated in the future with ticagrelor. • Female patients who are not pregnant or nursing an infant • Estimated risk of a major cardiovascular event (MACE) > 8% over next 3 years as defined by the presence of at least one or more of the following enrichment factors: • Age > 65 years • Serum creatinine > 1.5 mg/dL • Diabetes mellitus (Type 1 or Type 2) • 3-vessel coronary artery disease • Cerebrovascular disease and/or peripheral arterial disease • Left ventricular ejection fraction (LVEF) < 50% • Current cigarette smoker • Chronic systolic or diastolic heart failure • SBP > 140 (within past 12 mos) • LDL > 130 (within past 12 mos) Exclusion Criteria: • There will be no exclusions for any upper age limit, comorbid conditions, or concomitant medications other than oral anticoagulants and ticagrelor that are used at the time of randomization, or are planned to be used during the study follow-up. • Patients and sites interested in participating must be part of the listed health systems collaborators.
NCT02697916 STU00203465 For more information on this study please contact us: Nodal, Mercedes |
CardiAQ TMV 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 ca… 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.
NCT02718001 STU00204104 For more information on this study please contact us: Brady, Caitlin |
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. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin l… 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. 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 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. For more information on this study please contact us: Ritz, Michaela |
LIVE-HCM 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.
… 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. For more information on this study please contact us: Zinn, Sarah |
Gore TAG-TBE 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). Blo… 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.
Primary Inclusion Criteria:
NCT02777593 STU00203850 For more information on this study please contact us: Toaspern, Lillian |
Bolton RelayPro 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 tu… 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. Inclusion Criteria:
NCT03033043 STU00204570 For more information on this study please contact us: Brady, Caitlin |
P3 AVIV Registry This 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.
Participants in this study will have the investigational (experimental) Edwards SAPIE… This 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.
Participants in this study will have the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) to replace the failing bioprosthetic aortic valve access through the heart through a small incision is in the 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) 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 the 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 the heart.
Study participation 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 up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally. *Main Inclusion Criteria* Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency. *Main Exclusion Criteria* 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 is unstable, rocking, or not structurally intact.
NCT03003299 STU00204739 For more information on this study please contact us: Duquette, Audrey |
PRESERVED-HF 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 tes… 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..
NCT03030235 STU00204842 For more information on this study please contact us: Roshevsky, Daniel Scott |
EARLY TAVR 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, … 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. Inclusion Criteria: 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. Exclusion Criteria: 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.
NCT03042104 STU00204517 For more information on this study please contact us: Duquette, Audrey |
AMULET IDE 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 fibr… 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. Inclusion Criteria: 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. *Main Exclusion Criteria* 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 Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure 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 Heart attack within 90 days prior to randomization Left ventricular ejection Fraction (LVEF) 110 bpm
NCT02879448 STU00204852 For more information on this study please contact us: Carswell, Amy |
The Twelve Intrepid TMVR Pilot Study 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 (TMVR) System. This research study is an early fe… 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 (TMVR) 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. For more information on this study please contact us: Brady, Caitlin |
REDUCE II 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 sh… 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:
NCT03088033 STU00204899 For more information on this study please contact us: Roshevsky, Daniel Scott |
AAA Geometric Surrogates An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at lea… An Abdominal Aortic Aneurysm (AAA) is a balloon-like expansion of the aorta, the large artery that transports blood from the heart to the rest of the body, in the abdominal area just below the kidneys. As part of routine monitoring care for patients diagnosed with AAA, at least semi-annual evaluations are performed using imaging methods such as a computed tomography (CT) scan. Magnetic Resonance Imaging (MRI) is another method of creating pictures of the same vessels seen on a CT scan. MRI is a method for producing extremely detailed pictures of blood vessels without the need for x-rays. Radio waves, along with the magnetic field of a large magnet within the MRI machine, are used to make the pictures. MR images are used to detect and aid in the diagnosis of heart disorders and blood vessel diseases. For the purpose of this research, along with the routine CT scan, an additional scan called a ECG-gated MRI exam will be performed. This MRI exam does not involve any contrast, a dye used to make tissues, abnormalities or diseases processes more visible. This one-time MRI exam will be performed prior to anticipated elective AAA repair or during the course of periodic surveillance for AAA. This research study plans to enroll approximately 200 study participants at approximately 3 sites, including approximately 100 people at Northwestern. For more information on this study please contact us: Toaspern, Lillian |
ASAP-TOO This study will evaluate the safety and effectiveness of the WATCHMAN 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 Contro… This study will evaluate the safety and effectiveness of the WATCHMAN 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 WATCHMAN 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 WATCHMAN Device itself and the implantation procedure are the same as the FDA approved WATCHMAN. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMAN Device in this study is considered “investigational” because it has not been approved by the FDA for use without short-term OAC therapy.
Participants in this study will be in this research study for about 5 years. During this time, participants will be asked to come to clinic for 6-7 study visits, and the study team will contact participants 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.
Inclusion Criteria: Documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation. The subject has a calculated CHA2DS2-VASc score of 2 or greater. Deemed by two study physicians to be unsuitable for oral anticoagulation. Deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant. Able and willing to return for required follow-up visits and examinations. Exclusion Criteria: The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation). 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). Prior stroke (of any cause) or TIA within the 30 days prior to randomization. Prior bleeding event within the 14 days prior to randomization. History of atrial septal repair or has an ASD/PFO device. 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%.
NCT02928497 STU00205007 For more information on this study please contact us: Carswell, Amy |
A Phase III study to Assess the Safety and Efficacy of VM202 for DFU with PAD A Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients with Concomitant Peripheral Arterial Disease (PAD)
NCT02563522 STU00204945 For more information on this study please contact us: Toaspern, Lillian |
Perclot IDE The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. PerClot is a device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot.… The purpose of this research study is to find out if PerClot is safe and effective as a part of surgery to stop bleeding. PerClot is a device in granule form made from the starch of a potato. The starch has been engineered in a way that the powder absorbs water and helps to form a clot. This kind of device (topical hemostat) is intended for use in surgical procedures as an adjunctive hemostatic device when control of capillary, venular, and arteriolar bleeding by pressure, ligature, or other conventional procedures is ineffective or impractical. PerClot is left in your body after surgery. In animal studies, it has been found that PerClot is absorbed by the body in a few days after surgery. This has not been demonstrated in humans and can vary depending on the amount of device applied. This can also depend where it is applied.
This research study will collect follow-up data after PerClot is used. PerClot is an investigational device in the United States. This means it has not been approved by the Food and Drug Administration (FDA). PerClot has been an approved medical device in Europe since 2008.
This research study plans to enroll approximately 324 study participants at approximately 25 U.S. sites, including approximately 10 people from this institution. We expect that participants will be in this research study for approximately 6 weeks; however, if you currently have, or are diagnosed with cancer during the study, you will be contacted by the study coordinator on the telephone at 24 months after your surgery to ask questions about your general health.
Research Trial Contact Information:
For more information, participants and clinicians may contact the research team at (312) 926-4000 or heartresearch@northwestern.edu.
Primary Inclusion:
Primary Exclusion:
NCT02359994 STU00205144 For more information on this study please contact us: Brady, Caitlin |
INVESTED Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vac… Influenza infection (“the flu”) is known to be associated with a higher risk for heart problems. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared to the standard-dose flu vaccine. Both the high dose and standard dose flu vaccines called Fluzone® are being provided for use in the study by Sanofi Pasteur, which manufactures the vaccines. The standard dose vaccine is approved by the Food and Drug Administration (FDA) for protecting against influenza disease caused by influenza A and influenza B viruses. The high dose vaccine is approved by the FDA for the same reason, but only for adults who are at least65 years old. Thus its use with adults younger than 65 in this study is investigational. This study is recruiting patients who have had a heart attack or have heart failure.
NCT02787044 STU00205380 For more information on this study please contact us: Reinkensmeyer, Larissa |
ACTIVE: Edwards Cardioband System Pivotal Clinical Trial 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 so… 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:
NCT03016975 STU00205575 For more information on this study please contact us: Brady, Caitlin |
SERENADE The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease.
There are several drugs available to manage heart failure symptoms, but to date, no treatments ha… The purpose of this study is to find out whether a drug called “macitentan” works and is safe in patients with Heart Failure with Preserved Ejection Fraction and Pulmonary Vascular Disease.
There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease.
Macitentan may reduce unwanted effects of a chemical substance in the body called endothelin, which has been detected in increased amounts in patients with heart failure. Endothelin causes blood vessels to narrow and results in overgrowth of the muscle in the walls of the lung blood vessels and also of the heart. By blocking the action of endothelin, macitentan lowers the blood pressure in the pulmonary arteries, may slow down overgrowth of the heart muscle and may therefore improve your condition.
Macitentan has been tested and approved in the U.S. for other diseases, but is considered experimental for the use in this study.
We expect participants will be in this research study for 70 weeks, and will need to come to clinic for study visits 13 times.
We expect up to 5 people here will be in this research study out of 300 people in the entire study internationally.
Primary Inclusion:
Primary Exclusion:
NCT03153111 STU00205418 For more information on this study please contact us: Sanchez, Cynthia |
REVAMP REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of life for patients who have HFpEF, normal to small LV chambers, and ev… REVAMP: The purpose of this study is to see if pacing the right atrium of the heart at a higher rate for periods of time can help the left ventricle (LV) pump blood better, and if it improves exercise capacity and quality of life for patients who have HFpEF, normal to small LV chambers, and evidence of thickened walls. This study will be conducted with patients who have a market-released Medtronic dual chamber pacemaker with a Sleep Function, and have had this pacemaker for at least 6 months. Any Medtronic dual chamber pacemaker with the Sleep Function will qualify.In patients with HFpEF, the chamber of the heart that pumps blood out to the body tends to be stiff with thickened walls, reducing the amount of blood that can be pumped with each heartbeat. Previous research suggests that raising the heart rate may reduce the thickness of the heart chamber walls and increase the amount of blood pumped with each heartbeat.This research study plans to enroll approximately 40 study participants at approximately 5 sites, including approximately 15 people from this institution.
NCT03210402 STU00205515 For more information on this study please contact us: Reinkensmeyer, Larissa |
BAY16 REALIsM The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life condition… The study aims to explore two marketed devices, monitoring physical activity under real-life conditions in patients with HFpEF and HFrEF. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions. For more information on this study please contact us: Reinkensmeyer, Larissa |
APOLLO TMVR This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpos… This study is enrolling subjects with severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. The new investigational device is a mitral valve replacement called the IntrepidTM Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of the TMVR device is to function similarly to a standard bioprosthetic (man-made) valve implant in that it allows blood to flow only in the forward direction, relieving mitral regurgitation. A standard valve implant, however, is sewn directly into the heart during surgery in which the chest is fully open, the patient is put on 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 or stopping the heart. INCLUSION: 1) Subject has severe symptomatic mitral regurgitation as defined by the ASE. 2) Patient is a candidate for bioprosthetic mitral valve replacement EXCLUSION: 1) Prior mitral valve surgery including previously implanted mitral valve, ring, or band. 2) Heart Team agrees predicted risk of operative mortality is
NCT03242642 STU00206197 For more information on this study please contact us: Brady, Caitlin |
LMNA Cardiomyopathy This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if … This study is enrolling patients diagnosed with LMNA-related dilated cardiomyopathy (DCM), who have an irregular heart rhythm (arrhythmia) or their heart is not working properly (myocardial dysfunction). For this study, we are evaluating use of a medication, colchicine, to see if it can help improve heart function and reduce irregular heart rhythms in patients with LMNA related DCM For more information on this study please contact us: Roshevsky, Daniel Scott |
Ironwood CAPACITY HFpEF A Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction.
NCT03254485 STU00206096 For more information on this study please contact us: Reinkensmeyer, Larissa |
P3 MITRAL Valve in Valve 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 the failing valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in… 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 the failing 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. We expect that participation in this study will last approximately 10 years. Participants will have the study device implanted, and will need to come to clinic for 13 planned study visits.This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined)
NCT03193801 STU00205381 For more information on this study please contact us: Duquette, Audrey |
CIRB - Dilated Cardiomyopathy (DCM) Research Project Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary ar… Dilated cardiomyopathy (DCM) is a condition in which the heart becomes enlarged and the heart muscle weakened, causing the heart to pump blood less efficiently. DCM is commonly caused by heart muscle damage (“a heart attack”) from coronary artery disease. Other causes include exposure to some drugs, such as cancer chemotherapy. When the cause is unknown, it is called idiopathic DCM. Among individuals with idiopathic DCM, having relatives undergo a cardiac check-up (echocardiogram, ECG) will reveal familial DCM in up to one-third of cases. A high level of suspicion of familial DCM is also raised when family members have had heart failure, a heart transplant, sudden death (without a history of coronary artery disease), or arrhythmias, which sometimes require a pacemaker or defibrillator. WHAT DOES THIS STUDY INVOLVE? IF YOU HAVE IDIOPATHIC DCM: Participation involves inviting all your first-degree relatives (children, parents, siblings) with or without heart disease. If you have other more distant relatives with DCM, they are also welcome to participate. To help with this process, we provide a letter that you can share with your relatives, and a family history questionnaire for you to complete. You may also receive a communication tool to help you invite your family members to the study. Your participation also involves providing cardiovascular information and medical records, completing annual surveys, and a blood draw. FOR FAMILY MEMBERS: Participation of family members involves collecting cardiac information and a blood draw. To better understand the genetic cause of DCM, it is helpful to compare results from family members with and without the condition. Because DCM can be present but silent for years, it is difficult to know with certainty if a family member does or does not have DCM unless a cardiac check-up is performed. Medical guidelines recommend this for 1st degree family members of individuals with DCM. Therefore, we also ask family members who enroll to obtain cardiac screening with both an echocardiogram and an electrocardiogram (ECG) if
they have not done so recently. Inclusion Criteria: Meeting criteria for dilated cardiomyopathy (DCM) : Left ventricular ejection fraction 95%tile population standard based on gender and height). Detectable causes of cardiomyopathy, except genetic, excluded beyond a reasonable doubt at the time of DCM diagnosis (that is, meeting clinical criteria for idiopathic DCM) Any age (including children) Non-Hispanic and Hispanic ethnicity All races (PI pre-approval required for recruitment beyond pre-specified recruitment targets). Ability to give informed consent Ability to communicate in English (except Spanish language at sites approved to recruit individuals of Hispanic ethnicity) Willingness to participate in a family-based study (patient willing to work with a clinical site and/or OSU to facilitate the recruitment and enrollment of family members to the study). Exclusion Criteria: Coronary artery disease (CAD) causing ischemic cardiomyopathy (> 50% narrowing, any major epicardial coronary artery) Primary valvular disease Adriamycin or other cardiotoxic drug exposure Other forms of cardiomyopathy: Hypertrophic, Restrictive, or Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy Congenital heart disease Other detectable causes of dilated cardiomyopathy, including sarcoid and hemochromatosis. Other active multi-system disease that may cause DCM (e.g., active connective tissue disease). Severe and untreated or untreatable hypertension (systolic blood pressures routinely greater than 180 mm Hg and/or diastolic blood pressures greater than 120 mm Hg, and if resistant to multidrug treatment). However, conventional risk factors for DCM, including obesity, routinely treated hypertension, alcohol use, pregnancy or the peri-partum period, or left ventricular noncompaction, will NOT be considered exclusion criteria.
NCT03037632 STU00205850 For more information on this study please contact us: Whisler, Cailin |
HNO Donor (BMS CV013) This is a study of continuous 5-hour intravenous (IV) infusion of BMS-986231 in patients with heart failure and reduced ejection fraction (HFrEF). The trial is designed to evaluate the effects of BMS-986231 on systolic and diastolic parameters measured by echocardiography… This is a study of continuous 5-hour intravenous (IV) infusion of BMS-986231 in patients with heart failure and reduced ejection fraction (HFrEF). The trial is designed to evaluate the effects of BMS-986231 on systolic and diastolic parameters measured by echocardiography.
NCT03357731 STU00206615 For more information on this study please contact us: Dreisbach, Alexander |
LTI-301 INTREPID A phase 3 open-label study in patients with PAH to evaluate the long-term safety and tolerability of LIQ861. Primary Inclusion:
Primary Exclusion:
NCT03399604 STU00207215 For more information on this study please contact us: Zinn, Sarah |
TR Cardioband This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study … This study is recruiting patients with tricuspid regurgitation (a condition in which blood flow through the tricuspid valve of the heart flows in the wrong direction) that may benefit from a new tricuspid valve reconstruction system. This is an early feasibility clinical research study that will evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction System, (the “Study Device” ).
The Study Device includes an adjustable implant that is delivered and anchored to the tricuspid valve by a transfemoral delivery system, meaning it is inserted in a minimally invasive procedure through a puncture into a vein in the leg. The Cardioband Implant will be positioned around the tricuspid valve and will be adjusted to reduce the size of the valve, thus improving the tricuspid regurgitation.
Up to 15 patients will be enrolled in this study at up to 15 sites. All enrolled study patients will be assessed at the following intervals: screening/baseline, procedure, discharge, 1 month, 6 months, 1 year and annually for 5 years post implant procedure. For more information on this study please contact us: Christensen, Lyndsay |
TRANSFORM-HF This study is comparing torsemide to furosemide on long-term outcomes for patients that have been hospitalized for heart failure.
NCT03296813 STU00207456 For more information on this study please contact us: Martinez, Leslie |
MitraClip EXPAND This study is being conducted to collect information on the use and outcomes of the MitraClip System in everyday medical treatment. Participating in this study will not impact the treatment that you receive for your MR. Information about your health and the results of y… This study is being conducted to collect information on the use and outcomes of the MitraClip System in everyday medical treatment. Participating in this study will not impact the treatment that you receive for your MR. Information about your health and the results of your treatment with the MitraClip system will be collected and documented during the implantation procedure, while you are in the hospital,and from your regularly scheduled clinic visits at 30 days and 1 year after the implant. You will not need to come in for extra visits or have additional procedures done for the study. Study staff will call you 6 months after the implant to ask how you are feeling and if you have had any problems or side effects. This study is recruiting patients who will be receiving a MitraClip System device as part of their standard care for mitral regurgitation (MR).
NCT03502811 STU00207858 For more information on this study please contact us: Brady, Caitlin |
CardiAMP The objective of this clinical trial is to determine the safety and efficacy of the CardiAMP cell therapy system in patients with post-myocardial infarction heart failure. Primary Inclusion:
NCT02438306 STU00206166 For more information on this study please contact us: Roshevsky, Daniel Scott |
CLASP IID The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been dete… The objectives of this pivotal clinical trial are to evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair compared to the MitraClip system in the treatment of patients with symptomatic degenerative mitral regurgitation (DMR) and who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team. Primary Inclusion Criteria:
NCT03706833 STU00208635 For more information on this study please contact us: Brady, Caitlin |
CLASP TR EFS The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure tricuspid regurgitation. This … The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery, may temporarily alleviate some symptoms, but will not permanently alleviate the condition or cure tricuspid regurgitation. This is an early feasibility study, meaning patients agreeing to participate in this study will be one of the first patients in the USA to undergo repair of their tricuspid valve using this investigational (experimental) device system. The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System’s implant (composed of man-made materials). This study is being conducted in up to 8 US centers and will enroll 15 patients across all sites.
Participation in this research study will last about 5 years. For more information on this study please contact us: Christensen, Lyndsay |
TAVR UNLOAD The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow).&n… The purpose of this study is to evaluate the use of a device to treat patients with Heart Failure (HF - inability of the heart to pump enough blood to meet the body's needs) who have moderate aortic stenosis (AS - narrowing of the aortic valve resulting in obstructed blood flow). This clinical trial is comparing the safety and effectiveness of TAVR (Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 Transcatheter Heart Valve (the Study Valve) and OHFT (optimal heart failure therapy) versus OHFT alone in HF patients with moderate AS. The study valve has not been approved by the U.S. Food and Drug Administration (FDA) for use in this patient population, and therefore it's use in this study is considered investigational. This study is looking for patients with Heart Failure and moderate Aortic Stenosis. Aortic Stenosis is a narrowing of the aortic valve opening,which blocks blood flow from the heart and causes symptoms such as chest pain,fainting and shortness of breath.
NCT02661451 STU00208415 For more information on this study please contact us: Duquette, Audrey |