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.
- CardioBand (Mitral)
- Principal Investigator: Robert L. Smith, II, MD
- A randomized, control trial of CardioBand to optimized medical management for treatment of functional mitral regurgitation in patients who are poor surgical candidates.
- PASCAL (Mitral)
- 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.
Cardiology
- Pioneer HF
- Principal Investigator: Steven Kindsvater, MD
- A study to assess the effect of in-hospital initiation of sacubitril/valsartan tablets vs enalapril on the time-averaged proportional change of NT-proBNP from baseline in patients who have been stabilized following hospitalization for acute decompensated heart failure and reduced ejection fraction.
- PRECISION GRX
- Principal Investigator: Srini P. Potluri, MD
- A post-market registry to continue market surveillance of the second generation CorPath® GRX System by Corindus Vascular Robotics. The CorPath GRX System offers improvements in procedural control, enhanced workflow and radiation protection for physicians, patients and staff.
Electrophysiology and Left Atrial Appendage (LAA)
- Amulet (LAA)
- 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.
- PRECEPT (AF)
- Principal Investigator: J. Brian DeVille, MD
- A multicenter, international study to 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.
Vascular
- WISCR Coronary
- Principal Investigator: Dennis R. Gable, MD
- Collect clinical reference images using the study device (Spectral MD DeepView Wound Imaging System 2.0) in subjects with a variety of acute and chronic wounds (including but not limited to: burns, diabetic foot ulcers, venous stasis ulcers and others).
- 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.
- PSIDE
- Principal Investigator: William T. Brinkman, MD
- A physician supported/initiated study, in which patients with Type A dissections who are deemed at high risk for surgery will be considered for enrollment. Stents specifically designed for use in the ascending aorta will facilitate treatment.