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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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: Reinkensmeyer, Alexandra |
DMR- Intermediate Risk Post Surgery
The main objective of this project is to determine intermediate-term echocardiographic
outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical
risk who have undergone mitral valve surgery for degenerativ…
The main objective of this project is to determine intermediate-term echocardiographic
outcomes in Medicare eligible patients (65 years of age and older) with moderate surgical
risk who have undergone mitral valve surgery for degenerative mitral regurgitation.
For more information on this study please contact us: Warzecha, Anna |
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 |
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: Ganz, Stephanie |
EVOQUE 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… 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: Christensen, Lyndsay |
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: Warzecha, Anna |
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: Kats, Lauren |
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: Kats, Lauren |
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: Reinkensmeyer, Alexandra |
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: Christensen, Lyndsay |
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 its inten… 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: Kats, Lauren |
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 |
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: Hernandez, Alejandro |
AF-STOP To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF Primary Inclusion Criteria:
Primary Exclusion Criteria:
STU00207885 For more information on this study please contact us: Whisler, Cailin |
CLASP IID/IIF 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 … 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: Kats, Lauren |
DT PAS PSR This project is recruiting patients that receive a medical device, made by Medtronic Inc., for treatment of severe heart failure. Participants are being asked to join a research registryto collect information about them and their medical device a.A… This project is recruiting patients that receive a medical device, made by Medtronic Inc., for treatment of severe heart failure. Participants are being asked to join a research registryto collect information about them and their medical device a. Aregistry is a record of the experience from people around the world with thatdevice and its performance. Informationabout patients’ current devices can lead to new, safer and more effectivedevices for patients in the future. Participants agreeing to participate in this registry will continue toundergo the standard treatment as determined by their doctor. There will be nochanges to medical care and there will be no additional visits. Medtronic will collect information over time about how thedevice is working for as long as the patient has the device and are in this registry. For more information on this study please contact us: Hernandez, Alejandro |
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). … 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: Kats, Lauren |
REPAIR-MR The purpose of this researchstudy is to compare health outcomes of patients diagnosed with Primary MR whohave their MV repaired with open heart surgery, which is the current standardtreatment, to patients who have their Mitral Valve repaired with th… The purpose of this researchstudy is to compare health outcomes of patients diagnosed with Primary MR whohave their MV repaired with open heart surgery, which is the current standardtreatment, to patients who have their Mitral Valve repaired with the MitraClipSystem. The MitraClip System uses a less invasive procedure to repair themitral valve.
Subjects are asked to participatein this Study because they have moderate-to-severe or severe MR and it has beendetermined to have symptoms due to heart failure despite being treated with currentlyavailable therapies. MR occurs when the leaflets of your mitral valve do notclose properly causing blood to leak backward with each heartbeat. Since someof the blood leaks backward, the heart needs to pump more blood with each beatto push the same amount of blood forward.
The Study will enrollapproximately 500 subjects at up to 60 sites in Europe, United States, andCanada.The Study consists of two arms: Device Arm and Control Arm.
NCT04198870 STU00211557 For more information on this study please contact us: Kats, Lauren |
TRILUMINATE The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. … The purpose of this research study is to compare the safety and effectiveness of an investigational tricuspid valve repair system, called TriClip TM Device, which is inserted into the heart, along with using optimal drug therapy for your heart condition versus optimal drug therapy alone. The Study will enroll approximately 700 subjects at up to 80sites in Europe, United States and Canada. Up to 50 participants will be enrolled at Northwestern. The Study is made up of three different groups: Randomized(up to 450), Roll-In (up to 150, and Single-Arm Registry (up to 100).
NCT03904147 STU00210487 For more information on this study please contact us: Arroyo, Christina |