Cardiology and Pulmonary Hypertension
- AFFECTS
- Principal Investigator: David L. Brown, MD
- Assessment of Fractional Flow Reserve Computed tomography versus Single Photo Emission Computed tomography in the diagnosis of hemodynamically significant coronary artery disease.
- EMPEROR-Reduced
- Principal Investigator: Marcus McKenzie, MD
- The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guidance-directed medical therapy in patients with heart failure with reduced ejection fraction.
- RANGER II SFA
- Principal Investigator: Srini P. Potluri, MD
- To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries.
Electrophysiology and Left Atrial Appendage (LAA)
- aMAZE
- Principal Investigator: J. Brian DeVille, MD
- Left Atrial Appendage Ligation with the Lariat® Suture Delivery System as adjunctive therapy to pulmonary vein isolation for persistent or longstanding persistent atrial fibrillation.
- Amulet
- Principal Investigator: Srini P. Potluri, MD
- A study to assess the safety and efficacy of a new device, the Amulet (Abbott, Inc.) intended to reduce the risk of stroke and hemorrhagic events in patients who have atrial fibrillation.
- ASAP TOO
- Principal Investigator: Steven Kindsvater, MD
- The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.
Surgery
- Hybrid Coronary
- Principal Investigator: Robert L. Smith, II, MD / Molly Szerlip, MD
- The purpose of this study is to evaluate the effectiveness and safety of hybrid coronary revascularization (HCR) compared to multi-vessel percutaneous cardiac intervention (PCI) with metallic drug-eluting stents (DES) in patients with multi-vessel coronary artery disease (CAD) involving the left anterior descending (LAD) and/or left main (LM) arteries.
- VEST
- Principal Investigator: J. Michael DiMaio, MD / Kelley Hutcheson, MD
- To demonstrate the safety and effectiveness of the VEST for its intended use: Limiting intimal hyperplasia by providing permanent support to saphenous vein grafts which are being used as conduits in patients who undergo coronary artery bypass grafting procedures as treatment for coronary atherosclerotic disease.
Valve
- PARTNER 3 – Mitral Valve in Valve
- Principal Investigator: David L. Brown, MD
- To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.
- PASCAL
- Principal Investigator: Robert L. Smith, II, MD
- A nonrandomized safety and efficacy study for patients with severe mitral valve regurgitation, which hopes to offer this unique PASCAL edge-to-edge repair to a much wider range of mitral regurgitation patients.
Vascular
- Pivotal
- Principal Investigator: William T. Brinkman, MD
- Determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.