Study Title	Study Synopsis	Principal Investigator Research Coordinator
Atrial Fibrillation (AF) & Atrial Arrhythmia Studies
Protect AF Trial	A multi-center, randomized study comparing the WATCHMAN® left atrial appendage system to long-term Warfarin therapy in patients with atrial fibrillation. The WATCHMAN® device is permanently implanted in the left atrial appendage using a standard transseptal catheterization technique to prevent the occurrence of ischemic stroke and systemic embolization of thrombi. Patients will be followed at 45 days, 6 months, 9 months, 12 months and semi-annually thereafter post-randomization.	William Gray, MD Elena Hoskin
Carotid Studies
ACT I	A randomized trial evaluating carotid artery stenting using the Xact RX carotid stent and Emboshield cerebral protection system versus carotid endarterectomy in patients with asymptomatic extracanial carotid disease. The Emboshield is a percutaneous, temporary, transluminal filtration device designed to reduce distal embolization while maintaining blood flow during angioplasty and stent procedures. Patients will be followed at 1, 6, and 12 months post-procedure and annually for 5 years.	William Gray, MD Jeanie Sohn
Carotid DVA	A multi-center trial evaluating changes in Dynamic Vascular Analysis (DVA) indices in patients with carotid artery disease undergoing stenting procedure. When taken pre- and post-intervention, DVA indices may be able to correlate dynamic parameters of blood flow obtained from transcranial Doppler ultrasounds with clinical outcomes. Patients will be followed at 1 month post-procedure.	Issam Moussa, MD Jeanie Sohn
Capture II Trial	A multi-center, observational study collecting data on the FDA-approved RX ACCULINK Carotid Stent Systems and RX ACCUNET Embolic Protection Systems when used under commercial use conditions to identify rare or unanticipated device-related events. Patients will be followed at 30 days post-procedure.	Issam Moussa, MD Jeanie Sohn
CREST Trial	A multi-center, randomized trial to assess the efficacy of carotid artery stenting versus carotid endarterectomy in symptomatic patients with extracranial internal carotid stenosis (70% by duplex ultrasound or  50% by angiography) and asymptomatic patients with extracranial internal carotid stenosis (70% by duplex ultrasound or  60% by angiography). Patients will be followed at 14 days, at 1, 3, 6, 9, 12, 15 months post- procedure and annually for 5 years.	Issam Moussa, MD Jeanie Sohn
Chronic Renal Insufficiency (CRI) Studies
Be-Rite Registry	A multi-center, observational study collecting data on the FDA-approved BeNEPHit Infusion System when used under commercial use conditions. The BeNEPHit Infusion System is intended for the infusion of physician-specific agents in the peripheral vasculature including but not limited to the renal arteries. No follow-up visits are required.	Giora Weisz, MD
Cool RCN Trial	A multi-center, randomized study evaluating endovascular cooling with the Reprieve® System and hydration versus hydration alone in preventing radiocontrast nephropathy in patients undergoing diagnostic or interventional catheterization. Patients will be followed at 1 month post-procedure.	George Dangas, MD Miriam Lucca-Susana
Fen-002 Trial	A multi-center, randomized, placebo-controlled, dose-escalating study evaluating intra-renal fenoldopan administration with the Benephit infusion catheter in patients at high risk for radiocontrast nephropathy undergoing percutaneous coronary intervention (PCI). Fenoldopan is a vasodilator with potential to reverse or prevent renal vasoconstriction due to radiocontrast administration. Patients will be followed at 1 month post-procedure.	Giora Weisz, MD
Percutaneous Valve Replacement Studies
Everest II Pivotal Study	A multi-center, randomized study of the Evalve® Cardiovascular Valve Repair System versus mitral valve repair or replacement surgery in the treatment of mitral valve regurgitation. The Evalve® device enables placement of a clip on the mitral valve leaflets while the heart is beating resulting in permanent leaflet approximation similar to that with suture-based edge-to-edge repair techniques. Patients will be followed at 1, 6, and 12 months post- procedure and annually for 5 years.	William Gray, MD Miriam Lucca-Susana
Partners Trial	A multi-center, randomized study to determine the safety and efficacy of the Edwards SAPIEN Transcatheter Heart Valve in high risk symptomatic surgery patients undergoing transcatheter aortic valve implantation versus surgical aortic valve replacement and non-surgical patients undergoing transcatheter aortic valve implantation versus medical management. The study device is a catheter-delivered heart valve combining a balloon expandable stent and bioprosthetic valve made of bovine pericardium. Patients will be followed at 1, 6, and 12 months post- procedure and annually for 5 years.	Jeffrey W. Moses, MD Susheel Kodali, MD Marian Hawkey Elena Hoskin
Drug Eluting Stent (DES) Studies
Freedom Trial	A multi-center, randomized study to evaluate whether percutaneous coronary intervention (PCI) with drug-eluting stenting is more or less effective than coronary artery bypass surgery (CABG) in patients with Type 1 or 2 diabetes mellitus and multiple vessel cardiovascular disease. Patients will be followed at 1month post- procedure and annually for at least 3 years but up to 5 years.	George Dangas, MD Krisna Sricharoon
Spirit IV Trial	A multi-center, randomized study to evaluate the safety and efficacy of the Xience™ V coronary stent versus Taxus Express2 coronary stent in the treatment of subjects with de novo native coronary artery lesions. The Xience™ V device is an expandable cobolt chromium stent coated with Everolimus, an anti-proliferative drug which prevents in-stent restenosis. Patients will be followed at 1, 6, and 9 months post- procedure and annually for 5 years.	Michael Collins, MD Ashley Hill
Gene & Stem Cell Therapy Studies
Baxter Trial	A multi-center, randomized study evaluating safety, efficacy, and dose range of intramyocardial injections of G-CSF mobilized Auto-CD34+ cells to reduce angina episodes in subjects with refractory chronic myocardial ischemia who are not suitable candidates for conventional revascularization. Patients will be followed at 1 week and at 1, 3, and 6 months and up to 12 months post- procedure.	Warren Sherman, MD Jeanie Sohn
High Risk PCI
Protect I Trial	A multi-center, feasibility study investigating the safety and efficacy of the Impella™ Recover® LP 2.5 system in patients undergoing high risk elective percutaneous coronary intervention (PCI) an unprotected left main or last conduit coronary conduit. The study device is a miniaturized catheter-based cardiac assist device that pumps blood from the left ventricle to the systemic circulation across the aortic valve. Patients will be followed at 1and 3 months post- procedure.	Michael Collins, MD Susheel Kodali, MD Vanessa Laroche
PFO Closure
ESCAPE Migraine Trial	A multi-center, randomized trial to evaluate whether patent foramen ovale (PFO) closure with the Premere™ PFO Closure System is safe and effective in reducing migraine frequency in patients with at least a 12 month history of migraines versus medical therapy. The Premere™ PFO Closure System is a percutaneous, transcatheter self-expanding nitinol dual-anchor arm occlusion device. Patients will be followed monthly post- procedure for 1 year.	Robert Sommer, MD Ashley Hill
Coronary Vessel Imaging & Measurement Studies
GAAME Trial	A multi-center study using the Metricath Gemini System in the treatment of subjects with de novo native coronary artery lesion requiring percutaneous coronary intervention (PCI). The Gemini System is a percutaneous interventional device intended to pre-dilate an atherosclerotic lesion prior to stenting and perform post-stent arterial lumen measurements. Patients will be followed at 1month post- procedure.	Martin B. Leon, MD Elena Hoskin
Spectacle Trial	A multi-center study to characterize coronary artery plaque using the InfraReDx, Inc. Fiberoptic Near-Infrared Spectroscopic System in patients undergoing elective percutaneous coronary intervention (PCI). The study device is a coronary catheter designed to perform spectroscopic examination of coronary artery pathology using a near-infrared (NIR) laser spectroscopy. Patients will be followed at 1month post- procedure.	Jeffrey W. Moses, MD Krisna Sricharoon
Peripheral Vascular Disease
Vibrant Study	A multi-center, randomized study to evaluate the Gore Viabahni® Endoprosthesis stent versus bare Nitinol stent in the treatment of long lesions in the superficial artery. The Gore Viabahni® device is an ePTFE- lined nitinol self-expanding stent which should eliminate the development of in-stent restenosis and provide better mid- and long-term patency. . Patients will be followed at 1, 6, 12, 24 and 36 post-procedure.	William Gray, MD Krisna Sricharoon