Clinical Trials
Investigators at the Bluhm Cardiovascular Institute’s Clinical Trials Unit (BCVI-CTU) conduct clinical research trials on all aspects of heart and vascular disease. 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.
The following searchable list includes all Department of Medicine clinical trials currently looking for participants. Find information on participating in the research done through the BCVI-CTU via our Frequently Asked Questions page. For more information about our clinical trials, please contact the CTU Regulatory Team.
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MISCENDThis study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical 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 … This study is enrolling patients with moderate to severe mitral regurgitation who are considered to have high surgical 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 assess the safety and performance of a new bioprosthetic mitral valve device when implanted through groin (transfemoral) access. The new mitral valve replacement device is called the Edwards EVOQUE Eos System. The Edwards EVOQUE Eos 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 (transfemoral/transseptal).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 7 scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure. Patients with moderate to severe mitral regurgitation who are considered to have high surgical risk for traditional open-heart surgery. General Criteria:1. Greater than or equal to 18 years of age.2. New York Heart Associate Classification ≥ II3. Left Ventricular Ejection Fraction ≥ 30%.4. Mitral regurgitation (MR) ≥ Grade 3+ (moderate/severe, or severe).5. Patient is determined to be high surgical risk as assessed by the site’s ‘Heart Team’ (a minimum of one Cardiac Surgeon and one Interventional Cardiologist).
NCT02718001 STU00204104 |
Partner 3 AVIV RegistryThis 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 … 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. |
APOLLOThis study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (… This study is enrolling subjects with at least moderate-to-severe symptomatic mitral regurgitation to test a new investigational device for mitral regurgitation. A separate study cohort (MAC Cohort) will enroll subjects with at least moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC). The new investigational device is a mitral valve replacement called the Medtronic 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 IntrepidTM 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. Participation in this study will last for approximately 5 years. Participants will be expected to attend a minimum of 7 in-person scheduled study visits after discharge from the hospital at 1, 6, 12, 24, 36, 48 and 60 months after the procedure. Enrolling participants with mitral valve regurgitation who are at high risk of experiencing major complications while undergoing open-heart surgery due to their current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within the body). Additionally, physicians have determined that these participants may not be optimally treated with currently approved transcatheter repair therapies.
NCT03242642 STU00206197 |
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablationTo 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 |
CLASP IID/IIFThe 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 … 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 |
GSO 18-01 (REDUCE PAS)This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through a narrow opening into a small incision … This study is enrolling patients who have a patent foramen ovale (PFO), have had a stroke of unknown origin (cryptogenic stroke), and whose doctor has decided they are a candidate for a transcatheter procedure (a procedure performed through a flexible tube inserted through a narrow opening into a small incision in the skin) to close their PFO. A PFO is a common opening in the wall (septum) between the two upper chambers (the right and left atria) of your heart. In most cases, this opening closes around the time of birth. If the opening remains after birth, it can allow the blood to mix in the two upper chambers of the heart. This post-market study will look at closing the PFO to reduce the risk for another stroke using a market-approved medical device called a septal occluder. This device is called the ‘GSO device’ in this description. The GSO device is a minimally invasive device intended for the closure of a PFO using cardiac catheterization. It is a permanent implant consisting of a near circular wire frame covered with thin material. The soft, conformable material, invented and manufactured by Gore, has been used in open-heart surgery for more than 40 years and has been shown to be safe in implanted medical devices. The wire frame is made of a nickel-titanium metal alloy called nitinol with a platinum core (so that it may be seen on X-ray images).
NCT03821129 STU00209945 |
RV Ischemia & Fibrosis in CTEPHThis study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time … This study is enrolling patients who have been diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) and who are scheduled for a pulmonary endareterectomy (PEA) or balloon pulmonary angioplasty (BPA) procedure for treatment. CTEPH is high blood pressure in the arteries in the pulmonary system (lungs) caused by clots. Over time the clots typically leave scar tissue (fibrosis) in the arteries and lead to poor blood supply to the heart. In patients with CTEPH symptoms of heart failure commonly result from dysfunction (not working correctly) in the right ventricle (RV), or the chamber of the heart that pumps blood to the lungs. However, little is currently known about why or how that chamber of the heart becomes dysfunctional in patients with this condition. In another chamber of the heart, the left ventricle, it is known that elevated blood pressure in that chamber causes the development of diffuse fibrosis, or scarring between the muscle fibers, and a similar process may take place in the right ventricle of patients with CTEPH. For this study a cardiac magnetic resonance imaging (MRI) stress test (also known as stress CMR) will be done to look at the RV in patients with CTEPH before and 6 months after treatment. A stress CMR is a specialized scan of the heart that examines fibrosis (scarring) and blood flow (perfusion) both at rest and under stress. A gadolinium contrast agent (MRI dye) is given to highlight the heart muscle in areas receiving a good blood supply. Areas receiving less blood do not highlight as well as the good areas, which can be an indicator of ischemic heart disease (undersupply of blood and oxygen to the heart). |
TAMBE Pivotal AAA 17-01This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research … This study is enrolling patients who have an aortic aneurysm involving the visceral branch blood vessels (vessels that provide blood to the kidneys) that requires treatment. The aorta is a large blood vessel that carries blood away from the heart to organs in the rest of the body. This research study will look at treating thoracoabdominal or pararenal aneurysm disease with a new device design known as the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (the ‘Study Device’).The Study Device that will be used to treat the aneurysm is called a “stent-graft”. The Study Device combines a surgical graft material with an outer metal mesh-like form (stent). The nonmetal graft component of the Study Device is made of a soft, polymer material (ePTFE). This material is routinely and safely used for surgical procedures throughout the world today. The graft is surrounded on the outside with a metal frame made from an elastic metal (nitinol wire or stainless steel) bent into a wave pattern and shaped to fit the graft. The materials used in the Study Device are not investigational and have a long, safe history of performance in similar applications. |
REPAIR-MRThe purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less … The purpose of this research study is to compare health outcomes of patients diagnosed with Primary MR who have their MV repaired with open heart surgery, which is the current standard treatment, to patients who have their Mitral Valve repaired with the MitraClip System. The MitraClip System uses a less invasive procedure to repair the mitral valve. Subjects are asked to participate in this Study because they have moderate-to-severe or severe MR and it has been determined to have symptoms due to heart failure despite being treated with currently available therapies. MR occurs when the 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 needs to pump more blood with each beat to push the same amount of blood forward. The Study will enroll approximately 500 subjects at up to 60 sites in Europe, United States, and Canada. The Study consists of two arms: Device Arm and Control Arm.
NCT04198870 STU00211557 |
Angiotensin II for Distributive ShockAngiotensin II as a first-line vasopressor for distributive shock for heart transplant and left ventricular assist device implantation recipients: A Pilot Study Onset of distributive shock within 48 hours after heart transplantation or VAD placement at Northwestern Memorial Hospital
NCT04904562 STU00211528 |
Cardio-TTRansform (ION-682884-CS2)This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which … This study is enrolling patients who have transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) which is a disease caused by change in a protein called transthyretin (TTR). This change can either be sporadic which is known as wild-type (wtATTR-CM) or due to a mutation of the TTR gene which is hereditary (hATTR-CM). In both cases, these changes can cause the TTR to clump and build up in certain parts of the body such as the nervous system, stomach, intestines, and heart. This build up is called an amyloid deposit. Amyloid deposits can sometimes cause heart disease or neuropathy (nerve damage). When amyloid is deposited into the heart, it can result in a condition referred to as cardiomyopathy. ION-682884 is an investigational drug. “Investigational” means that ION-682884 is not yet approved for use in any settings outside of clinical research studies like this one and is considered experimental. ION-682884 reduces the level of TTR in the blood of animals and healthy volunteers tested to date. Reducing the amount of TTR in the blood may reduce the amount of amyloid deposits in the body and may keep cardiomyopathy from getting worse over time. However, it is not known if ION-682884 will help cardiomyopathy. The purpose of this study is to evaluate the safety of ION-682884 and determine if it can help people with this type of cardiomyopathy. |
Prospective evaluation of an applied ATTR-CM Machine Learning model to a health system electronic health record (EHR)This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. … This study is enrolling patients who have a diagnosis of congestive heart failure in their medical record, and is interested in determining whether one can use an automated, computer-based method to diagnose a specific cause of heart failure (“transthyretin cardiac amyloidosis”) based on other diagnoses in the medical record. Transthyretin cardiac amyloidosis is a rare disease that results from a protein in the body that becomes misfolded and starts depositing into the heart, a process known as amyloidosis. Because of these proteins getting into the heart muscle, the heart can get stiff and weak, thereby leading to congestive heart failure. Typically this form of heart disease (cardiac amyloidosis) is diagnosed late in its course and it associated with poor survival. However, there are now treatments for this disease, so earlier diagnosis is better. A machine learning (artificial intelligence)-based method to find potential patients with cardiac amyloidosis has been developed. This computer program automates finding patients who may have cardiac amyloidosis based on their other diagnoses in the electronic health record. This study seeks to validate the computer algorithm prospectively to see if it can be useful in patients to determine whether or not cardiac amyloidosis is the cause of heart failure. |
TRISCEND IIThis study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if … This study is recruiting patients with Tricuspid Regurgitation (TR), a condition in which the heart’s tricuspid valve does not close tightly which causes the blood to flow in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. The goal of this trial is to evaluate the safety and effectiveness of the Study Device with Optimal Medical Therapy (OMT) compared to OMT alone in the study of subjects with severe or greater tricuspid regurgitation. |
CatalystThis study is enrolling patients in whom the Amulet device could be beneficial in reducing the risk of ischemic stroke due to non-valvular atrial fibrillation (AF). The purpose of this research study is to compare the safety and effectiveness of the Amulet device compared to non-vitamin K antagonist … This study is enrolling patients in whom the Amulet device could be beneficial in reducing the risk of ischemic stroke due to non-valvular atrial fibrillation (AF). The purpose of this research study is to compare the safety and effectiveness of the Amulet device compared to non-vitamin K antagonist oral anticoagulants (NOACs) for ischemic stroke risk reduction. NOACs are a class or type of drugs taken daily, which thin the blood to reduce blood clots and the risk of an ischemic stroke. An ischemic stroke occurs when a small clot prevents blood and oxygen from reaching part of the brain. While NOACs are effective in preventing blood clots and ischemic stroke, thinning of the blood can increase the risk for bleeding events. The Amulet device is intended to be permanently implanted within the LAA. The LAA is a small pouch attached to the upper left chamber of the heart, the left atrium. In patients with non-valvular atrial fibrillation, clots can form in the LAA and travel to the brain, sometimes causing an ischemic stroke. The Amulet device is designed to seal off the LAA from blood flow, preventing clots from leaving the LAA and traveling to the brain. This is accomplished without the need for NOACs or warfarin in most cases. |
DAPA ACT HF-TIMI 68This study is recruiting patients who are hospitalized for acute heart failure. This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart is … This study is recruiting patients who are hospitalized for acute heart failure. This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart is not pumping enough blood with each heartbeat. |
MRI vs Echo: MR-TRThis study is recruiting patients who have had or are scheduled to have an intervention to repair or replace their mitral or tricuspid valve. The purpose of this study is to improve the assessment of mitral or tricuspid regurgitation before and after percutaneous or surgical intervention.… This study is recruiting patients who have had or are scheduled to have an intervention to repair or replace their mitral or tricuspid valve. The purpose of this study is to improve the assessment of mitral or tricuspid regurgitation before and after percutaneous or surgical intervention. |
CY6022A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM)
NCT04848506 STU00214844 |
PROTECT IV TrialThis study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function. The purpose of this study is to assess … This study is recruiting patients who are scheduled to have a heart procedure called a Percutaneous Coronary Intervention (PCI) and may be at risk of potential problems during the procedure because they have complex heart disease and reduced left heart function. The purpose of this study is to assess if using an Impella device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function, and health after the heart procedure compared to the current standard of care. |
LUX-Dx TRENDSThis study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM). Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the … This study is recruiting patients whose medical tests show they have heart failure, and whose doctors have determined that they would benefit from an insertable cardiac monitor (ICM). Heart Failure is a condition that makes the heart muscle weak and the heart cannot pump as much blood as the body needs. Sensors have been added to the ICM to determine whether they can provide doctors who treat patients with similar conditions with additional information to help analyze their heart failure condition. The study will gather information about the sensors. |
Impella BTR EFSUse of the Impella BTR™ in Patients with Heart Failure: An Early Feasibility Study
NCT05291884 STU00216603 |
REBIRTHThe study will enroll women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.
NCT05180773 STU00217144 |
PERSEVERETo assess the safety and effectiveness of AMDS to treat patients with acute DeBakey type I dissection with evidence of radiographic and/or clinical malperfusion, through open surgical repair.
NCT05174767 STU00216770 |
DEFINE-HTDevelopmEnt of non-invasive cell-Free DNA to supplant INvasivE biopsy in Heart Transplantation (DEFINE-HT) Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant. NCT05309382 STU00217683 |
LeAAPS TrialLeft Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
NCT05478304 STU00217732 |
REHAB-HFpEFPhysical Rehabilitation for Older Patients with Acute Heart Failure with Preserved Ejection Fraction (REHAB-HFpEF)
STU00218196 |
ADVANTAGE-AFA Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects with Persistent Atrial Fibrillation Subjects having symptomatic, documented, drug-resistant, Persistent AF
NCT05443594 STU00217834 |
RESPONDER-HFRe-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure
NCT05425459 STU00217812 |
REACT-AFRhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation
NCT05836987 STU00219005 |
CY 6032A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO METOPROLOL IN ADULTS WITH SYMPTOMATIC OBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography
NCT05767346 STU00219019 |
SEISMIC-HF INon-invasive Seismocardiogram In Cardiovascular monitoring for Heart Failure I
NCT00000000 STU00215330 |
CY 6033 ACACIATRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NONOBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY
NCT06081894 STU00219608 |
Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD)The purpose of the study is to further assess the safety and effectiveness of the Shockwave Coronary IVL system (“Study Device”) in the arteries of your heart. NCT05755711 STU00219788 |
EXTENDThoraflex Hybrid and Relay Extension Post-Approval Study Patient will undergo treatment with a Thoraflex Hybrid device
NCT05639400 STU00219308 |
ARISE-IIEvaluation of the GORE® Ascending Stent Graft (ASG device) in the Treatment of Lesions of the Ascending Aorta
NCT05800743 STU00219695 |
Preserve Heart StudyStudy of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors Listed for heart transplantation
NCT05881278 STU00220133 |
ALT-FLOW IIClinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II)
NCT05686317 STU00220238 |