Access to the newest clinical trials available at premier academic medical centers is an important aspect of providing innovative care to our patients. Our cardiovascular medicine and surgery experts are leading clinical trials as national principal investigators in multi-institutional studies, bringing the therapies of tomorrow to UPMC today.
The UPMC Heart and Vascular Institute offers clinical trials in all sub-specialties of cardiovascular medicine and surgery, including heart failure, electrophysiology, heart valve disease, coronary artery disease, and more.
If you are considering participation in a clinical trial, it is important to:
Search the US government's clinical trial database now for heart and vascular trials.
PI: Raveen Bazaz, MD
Research Coordinator: Eric Pasquantonio
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX™ device is a reasonable alternative to non-vitamin K oral anticoagulants (NOACS) in patients with non-valvular atrial fibrillation. Looking for patients with non-valvular atrial with CHA2DS2-VASc score of two or greater for men and three or greater for women.
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PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny
Study looking to evaluate safety and effectiveness of Abbott’s Nanostim LP system in patients who are indicated for VVI (R) pacemaker. Eligible subjects must have one of following: Chronic and/or permanent atrial fibrillation with two or three degree AV or bifascicular BBB, including slow ventricular rates associated with AFib; or NSR with two or three degree AV or BBB and a low level of physical activity or short expected lifespan (at least one year), or sinus bradycardia with infrequent pauses or unexplained syncope with electrophysiology (EP) findings.
PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny
Post-approval study to evaluate health outcomes in patients implanted with the OPTIMIZER™ Smart in a real-world setting. Looking for patients with heart failure who meet the criteria for cardiac contractility modulation (CCM) therapy. The OPTIMIZER device has been approved for standard of care implant. Looking for patients with New York Health Association (NYHA) class III symptoms and reduced (HFrEF) or moderately reduced ejection fraction (25-45%).
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PI: Raveen Bazaz, MD
Research Coordinator: Liz Benckart
The primary objective is to determine if left atrial appendage closure with the WATCHMA N FLX™ device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high-risk patients with non-valvular atrial fibrillation (AFib). Looking for patients with non-valvular atrial with CHA2DS2-VASc score of two or greater for men and three or greater for women who underwent catheter ablation procedure for non-valvular AFib between 90-180 days prior (sequential) or will have ablation within 10 days of randomization (concomitant).
PI: Sandeep Jain, MD
Research Coordinator: Susan Sweeny
Safety and Effectiveness IDE trial of Medtronic’s Pulse Select PFA system for the treatment of atrial fibrillation. Looking for subjects indicated for ablation procedure for Symptomatic paroxysmal or persistent AF who have failed at least one AAD (class I or III).
PI: Samir Saba, MD
Research Coordinator: Susan Sweeny
Study evaluating safety and effectiveness of the WiSE CRT System. The WiSE CRT System provides endocardial left ventricular stimulation, synchronized to the right ventricular pacing output pulse of a commercially available pacemaker, ICD, or CRT to achieve cardiac resynchronization therapy. Looking for previously untreatable CRT patients or high-risk bpgrades and meeting established CRT treatment criteria.
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PI: Aditya Bhonsale, MD
Research Coordinator: Eric Pasquantonio
The trial will evaluate changes in left ventricular end-systolic volume (LVESV) between baseline (before CRT implant) and 12 months (post-randomization) in patients with cardiac resynchronization therapy (CRT) devices programmed with SyncAV compared to patients with CRT devices programmed with fixed atrioventricular (AV) delay. Looking for patients to receive a new CRT implant or upgrade (Abbott CRT device and Abbott Quadripolar LV Lead) to an existing implantable cardioverter defibrillator/pacemaker implant with no prior LV lead placement AND have HF, LVEF ≤ 35%, LBBB, and intact atrioventricular conduction.
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PI: Mary Keebler, MD
Research Coordinator: Abbey Sung
A randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients with the HM3 with two different antithrombiotic regimens.
PI: Gavin Hickey, MD
Research Coordinator: Rachel McGargle
A prospective, multi-center, randomized, controlled, single blind clinical trial evaluating the safety and efficacy of the cordella pulmonary artery sensor system in New York Heart Association (NYHA) Class III heart failure patients
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PI: Jess Huston, MD
Research Coordinator: Kristin Shoemaker
A phase 1/1b clinical trial of ABI-009, an mTOR inhibitor, for patients with pulmonary arterial hypertension.
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PI: Mary Keebler, MD
Research Coordinator: Traci McGaha
A prospective, multi-center, observational registry of patients receiving HeartCare for rejection surveillance following heart transplant.
PI: Prem Soman, MD
Research Coordinator: Tracy Nicholson
A phase 3 global, double-blind, randomized, placebo controlled study to evaluate the efficacy and safety of ION-682884 in patients with transthyretin mediated amyloid cardiomyopathy (ATTR CM).
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PI: Timothy Wong, MD
Research Coordinator: Jenny Whitehead
A multi-center, randomized, double blinded, placebo controlled, dose finding study to evaluate the safety and tolerability, pharmokinentics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction.
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PI: Catalin Toma, MD
Research Coordinator: Jenny Whitehead
A prospective, multi-center, dual arm pivotal study with 2:1 active concurrent control group allocation ratio. The Revivent TC system is indicated in patients suffering from symptomatic heart failure referred for treatment of left ventricular aneurysms.
PI: Conrad Smith, MD
Research Coordinator: Brianna Carbone
Prospective, randomized controlled study of the Triclip™ device in symptomatic patients with severe tricuspid regurgitation.
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PI: Catalin Toma, MD
Research Coordinator: Brianna Carbone
The primary objective of this observational study is to evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism who have received treatment with the FlowTriever System compared to an established performance goal (literature-based goal). In addition to the primary objective, outcomes of patients diagnosed with high-risk (massive) pulmonary embolism who have received treatment with other (non-FlowTriever) therapies will also be analyzed.
PI: Catalin Toma, MD
Research Coordinator: Brianna Carbone
The primary study objective is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.
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PI: Catalin Toma, MD
Research Coordinator: Jenny Whitehead
This multicenter trial randomly allocates 3,500 patients with acute myocardial infarction and a hemoglobin concentration less than 10 g/dL to be treated either according to a liberal or restrictive blood transfusion strategy.
PI: John Pacella, MD
Research Coordinator: Jenny Whitehead
Randomized, double-blinded, sham controlled single cohort study designed to demonstrate the effectiveness and safety of the Paradise renal denervation system in hypertensive subjects.
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PI: Catalin Toma, MD
Research Coordinator: Jenny Whitehead
Drug eluted balloon used for in stent re-stenosis.
PI: Jeff Fowler, MD
Research Coordinator: Brianna Carbone
Impella™ unloading to lessen heart failure after ST-Elevation Myocardial Infarction (STEMI).
PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
The purpose of this study is to determine the safety and effectiveness of a device called QuikClot Control+ Hemostatic Dressing to control mild and moderate bleeding known to occur at the access site into the heart, such as the sternum, or at the suture lines during a cardiac surgical procedure.
PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
We are currently recruiting patients for a research study: A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban. This study is sponsored by Cryolife, Inc.
The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban, an anticoagulant drug different from warfarin. We are looking to recruit patients who have already been implanted with the On-X aortic valve.
PI: Ibrahim Sultan, MD
Research Coordinator: Missy Sanders Linger
This research project is testing a new investigational device for mitral regurgitation without the need for open heart surgery. The new investigational device is a mitral valve replacement called the Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System. The purpose of this clinical study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions.
PI: Ibrahim Sultan, MD
Research Coordinator: Stephanie Trbovich
The purpose of this study is to learn more about how well this device works and to learn about the effects of following a particular set of steps when treating a patient with the Evolut PRO or EVOLUT PRO+ system.
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PI: Ibrahim Sultan, MD
Research Coordinator: Missy Sanders Linger
The purpose of this trial is to evaluate a new investigational device called the Tendyne™ Mitral Valve System. The Tendyne Mitral Valve System is designed for the treatment of a diseased, damaged or malfunctioning mitral valve. This trial will collect information on how safe and effective this device is to treat a leaking mitral valve as compared to the commercially available (approved by the FDA) MitraClip® System. The MitraClip System consists of a delivery catheter and an implantable Clip that is designed to repair the mitral valve by clipping the two leaflets together.
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PI: Ibrahim Sultan, MD
Research Coordinator: Kristin Konopka
An international, multi-center, randomized, open-label, clinical trial comparing the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 or SAPIEN 3 Ultra transcatheter heart valve (THV) and optimal heart failure therapy (OHFT) versus OHFT alone in heart failure patients with moderate aortic stenosis.
PI: Michael Singh, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
Prospective, non-randomized, multi-center study with two independent arms (TAAA requiring only TAMBE system and TAAA requiring TAMBE system and CTAG device(s) to assess the safety and effectiveness of the TAMBE Device in the treatment of thoracoabdominal and pararenal aortic aneurysms.
Inclusion criteria: Patients with aortic aneurysm involving the visceral vessels requiring treatment defined as fusiform aneurysm diameter ≥ 5cm, saccular aneurysm, or rapid aneurysm growth as well as appropriate aortic anatomy to receive the TAMBE device
PI: Rabih Chaer, MD
Research Coordinator: Julianna Sheline, 412-235-1304; Judith Brimmeier, 412-623-8486
Prospective, multi-center registry evaluating the real-world therapeutic strategies, clinical outcomes, and costs associated with patients presenting with critical limb ischemia.
Inclusion criteria: Infrainguinal peripheral artery disease, critical limb ischemia defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-6.
PI: Rabih Chaer, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
A prospective, non-randomized, multi-center study to demonstrate the efficacy of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
Inclusion criteria: PE symptom duration ≤ 14 days, filling defect in at least one main or lobar pulmonary artery as determined by CTA, RV/LV diameter ratio ≥ 0.9 by CTA
PI: Eric Hager, MD
Research Coordinator: Julianna Sheline, 412-235-1304; Judith Brimmeier, 412-623-8486
A randomized, multi-center, assessor-blind trial to determine if the use of imaging-guided endovascular therapy (EVT) is an effective strategy with which to reduce PTS disease severity and improve QOL in patients with established DIO-PTS (Disabling Iliac Occlusion-Post Thrombotic Syndrome).
Inclusion criteria: Disabling (moderate-to-severe) PTS with VCSS ≥ 8 or Villalta ≥ 10 or open ulcer and iliac vein obstruction (occlusion or > 50% area stenosis).
PI: Rabih Chaer, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
A prospective, single-arm, non-blinded, multi-center clinical trial to investigate the safety and efficacy of the Vesper DUO Venous Stent System in the treatment of subjects presenting with iliofemoral occlusive disease.
Inclusion criteria: Patients with nonmalignant iliofemoral venous outflow obstruction presenting with non-thrombotic, acute thrombotic, or chronic post-thrombotic disease.
PI: Michael Singh, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
A prospective, non-randomized study to evaluate the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the treatment of lesions of the aortic arch and the descending thoracic aorta.
Inclusion criteria: Patients > 18 years of age with thoracic aortic lesions which require coverage of the left subclavian artery, left common carotid artery and/or the brachiocephalic trunk/innominate artery for effective treatment and have anatomy suitable for treatment with the TAG® TBE Device
PI: Georges Al-Khoury, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
A prospective, non-randomized study to assess the safety and effectiveness of the CEXC device for the treatment of infrarenal AAA. The CEXC device will allow endovascular treatment in hostile infrarenal aortic anatomy characterized by either a short proximal seal zone and/or excessive proximal neck angulation.
Inclusion criteria: Patients > 21 years of age with a AAA that meet any of the following criteria: Maximum diameter ≥ 50 mm, Rapid growth (> 5 mm in a six-month period) or, Non-ruptured AAA presenting with clinical symptoms and have anatomy suitable for treatment with the CEXC device.
PI: Theodore Yuo, MD
Research Coordinator: Julianna Sheline, 412-235-1304; Judith Brimmeier, 412-623-8486
Pilot of randomized trial of fistula versus graft in elderly patients.
Inclusion criteria: Patients on hemodialysis through a tunneled dialysis catheter and, in the surgeon’s opinion, both a fistula and a graft can be reasonably attempted based on the patient’s anatomy.
PI: Theodore Yuo, MD
Research Coordinator: Judith Brimmeier, 412-623-8486; Julianna Sheline, 412-235-1304
A prospective, randomized, controlled multi-center clinical trial comparing the Merit WRAPSODY Endovascular Stent Graft to percutaneous transluminal angioplasty for the treatment of venous outflow circus stenosis or occlusion in hemodialysis patients.
Inclusion criteria: Patients with an AVG or AVF who have stenosis or occlusion
The Pitt+Me Registry is a program at the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) that engages researchers, patients, and volunteers from the greater Pittsburgh community in an effort to advance science and improve health for future generations.
We encourage you to join the more than 100,000 participants in the Pitt+Me Registry who have signed up to receive our newsletter and hear more about research opportunities that may be of interest.
Learn more about research studies and clinical trials that are related to heart and circulation.
An advantage in choosing the UPMC Heart and Vascular Institute for your cardiovascular care is that many of our physicians are also nationally and internationally renowned physician-scientists. These experts maintain active clinical research and basic science laboratories funded by the National Institutes of Health. Learn more about the centers and cores at the Pittsburgh Heart, Lung, Blood, and Vascular Medicine Institute and how our multidisciplinary team of scientists is advancing research in the heart, lung, and blood systems.