Heart Valve
- Early TAVR
- Principal Investigator: David L. Brown, MD
- Establish the safety and effectiveness of the Edwards SAPIEN 3™ (Edwards Lifesciences™, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- 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.
- TAVR in MAC (SITRAL)
- Principal Investigator: Robert L. Smith, II, MD
- The purpose of this study is to establish the safety and feasibility of the Edwards SAPIEN 3 valve in subjects with mitral annular calcification (MAC) associated with mitral stenosis (MS) and/or mitral regurgitation who are at risk for mitral valve surgery due to the extent of calcification.
Cardiothoracic and Vascular Surgery
- GORE® TAG® TBE (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.
Electrophysiology
- Lariat®
- Principal Investigator: Brian DeVille, MD
- To assess the utility of left atrial appendage ligation with the SentreHEART Lariat® device in improving the success of ablation in participants with persistent atrial fibrillation.
- PRECEPT (AF)
- Principal Investigator: J. Brian DeVille, MD
- Demonstrate the safety and effectiveness of the THERMOCOOL SMARTTOUCH® SF catheter in the treatment of drug refractory in symptomatic, persistent atrial fibrillation following standard electrophysiology mapping and RF ablation procedures.
Coronary Artery Disease
- AFFECTS
- Principal Investigator: David L. Brown, MD
- To correlate the Heartflow technology to gold standard of cardiac catheterization with FFR after a positive SPECT scan.
- EVOLVE
- Principal Investigator: Molly Szerlip, MD
- Assess the safety of 3-month DAPT in subjects at high risk for bleeding undergoing PCI with the SYNERGY™ Stent System.