Clinical Trials

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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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Showing 1 to 10 of 33 entries

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Trials
AF STOP: AF Substrate as an Outcome and Predictor of successful AF ablation To improve the understanding of factors associated with the atrial myopathy in people with AF or people at risk for developing AF Eligibility CriteriaPrimary Inclusion Criteria: Patients ≥ 18 years old Patients with paroxysmal or early persistent AF undergoing routine pulmonary vein isolation (PVI) Subjects who are scheduled to undergo clinically ordered cardiac MRI for planning of AF ablation Primary Exclusion Criteria: Longstanding persistent AF (continuous AF > 1 year) or AF from a reversible cause Previous catheter or surgical ablation for AF Contraindication to MRI Advanced chronic renal insufficiency (GFR < 30 mL/min/1.73 m2), anemia (hemoglobin < 10 g/dL) or thrombocytopenia (platelet count < 100K/UL) History of pulmonary emboli, CVA or TIA (within the past 6 months), atrial clot/thrombus on imaging, or blood clotting/bleeding abnormalities Principal Investigator Passman, Rod S Location(s) Map it 201 E. Huron St. Chicago, IL IRB number STU00207885 More Info Keywords Atrial Fibrillation (AFib) Pulmonary Vein Isolation (PVI) MRI Email Stat, Madison Rose Phone +1 312 926 3926 Copy Study URL to Clipboard Copy
ALT-FLOW II Clinical trial for evaluation of the Edwards APTURE transcatheter shunt system (ALT-FLOW II) Eligibility Criteria Chronic symptomatic heart failure (HF) due to non-valvular and noncongenital left heart disease (LHD) on stable medically optimized guideline-directed medical therapy (GDMT) for HFpEF/HFmrEF, for >30 days Principal Investigator Flaherty, James D Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05686317IRB number STU00220238 More Info Keywords APTURE Shunt Email Roshevsky, Daniel Scott Phone +1 312 695 3264 Copy Study URL to Clipboard Copy
APOLLO 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 (… 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. Eligibility CriteriaEnrolling 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. Principal Investigator Malaisrie, S. Chris Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03242642IRB number STU00206197 More Info Keywords Mitral Valve Regurgitation (MVR) Transcatheter Mitral Valve Repair (TMVR) Email Cortez, Justin Phone Copy Study URL to Clipboard Copy
ARISE-II Evaluation of the GORE® Ascending Stent Graft (ASG device) in the Treatment of Lesions of the Ascending Aorta Eligibility Criteria Ascending Aortic pathologies warranting surgical repair Anatomic compatibility with the ASG device based on Gore Imaging Sciences review Must be considered high-risk for open surgical repair Principal Investigator Mehta, Christopher Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05800743IRB number STU00219695 More Info Keywords GORE Ascending Stent Graft ASG Email Silverman, Andrea Raye Phone Copy Study URL to Clipboard Copy
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. Principal Investigator Shah, Sanjiv J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04136171IRB number STU00211443 More Info Keywords ATTR Transthyretin-Mediated Amyloid Cardiomyopathy ATTR CM Email San Emeterio, Lis Phone Copy Study URL to Clipboard Copy
Catalyst 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 … 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. Principal Investigator Knight, Bradley Paul Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT04226547IRB number STU00212364 More Info Keywords Atrial Fibrillation Afib Amulet Email George, Neal Phone Copy Study URL to Clipboard Copy
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 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. Eligibility Criteria Primary Inclusion Criteria: Patient is determined to be at prohibitive risk for mitral valve surgery by a heart team Mitral regurgitation (3+ to 4+) by echo (TTE or TEE) as measured by the core lab Left ventricular ejection fraction (LVEF) ≥ 20% Principal Investigator Davidson, Charles J Location(s) Map it 201 E. Huron St. Chicago, IL ClinicalTrials.gov IdentifierNCT03706833IRB number STU00208635 More Info Keywords Mitral Valve Regurgitation MVR Transcatheter Mitral Valve Repair TMVR MitraClip Email Patalino, Jessica Phone Copy Study URL to Clipboard Copy
CY 6032 A 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 Eligibility Criteria Diagnosed with oHCM per study criteria by cardiac magnetic resonance imaging (CMR) or echocardiography Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT05767346IRB number STU00219019 More Info Keywords HCM Email Yang, Jason Phone Copy Study URL to Clipboard Copy
CY 6033 ACACIA TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AFICAMTEN COMPARED TO PLACEBO IN ADULTS WITH SYMPTOMATIC NONOBSTRUCTIVE HYPERTROPHIC CARDIOMYOPATHY Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT06081894IRB number STU00219608 More Info Keywords HCM Non-Obstructive HCM AFICAMTEM Email Yang, Jason Phone Copy Study URL to Clipboard Copy
CY6022 A FOLLOW-UP, OPEN-LABEL, RESEARCH EVALUATION OF SUSTAINED TREATMENT WITH AFICAMTEN (CK3773274) IN HYPERTROPHIC CARDIOMYOPATHY (HCM) Eligibility Criteria Completion of a Cytokinetics study investigating CK-3773274. If unable to complete due to circumstances not related to compliance or safety, Medical Monitor may review and determine eligibility. LVEF ≥ 55% Principal Investigator Choudhury, Lubna Location(s) Map it 675 N. Saint Clair St. Nineteenth Floor, Suite 100 Chicago, IL ClinicalTrials.gov IdentifierNCT04848506IRB number STU00214844 More Info Keywords HCM Email Yang, Jason Phone Copy Study URL to Clipboard Copy