WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Atrial Fibrillation, Stroke
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Blood thinning medication, transient ischemic attack (TIA), WATCHMAN, Left atrial appendage, LAA isolation, LAA occlusion
Eligibility Criteria
Inclusion Criteria: Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF) Eligible for long term warfarin CHADS score >= 1 [congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)] Exclusion Criteria: Contraindicated for warfarin Contraindicated for aspirin or clopidogrel (Plavix) Congestive heart failure (CHF) Class 4 Implanted mechanical valve Atrial septal or Patent Foramen Ovale (PFO) device Platelets < 100,000 or hemoglobin < 10 Left ventricular ejection fraction (LVEF) < 30%
Sites / Locations
- Advanced Cardiac Specialists
- Arizona Arrhythmia
- Foundation for Cardiovascular Medicine
- Los Angeles Cardiology Associates
- Cedars-Sinai Medical Center
- El Camino Hospital
- Orange County Heart
- UC Davis Medical Center
- St. John's Hospital / Pacific Heart
- Washington Hospital Center
- University of Miami
- Baptist Cardiac and Vascular Institute
- Bay Heart Group
- Emory University Midtown Hospital
- Piedmont Hospital
- Emory University Hospital
- University of Chicago
- North Shore University
- Loyola University Medical Center
- Prairie Education Research Cooperative
- Baptist Hospital West
- University of Kentucky
- Terrebonne General Medical Center
- Ochsner Clinic
- Massachusetts General Hospital
- University of Michigan Medical Center
- William Beaumont
- Abbott Northwestern Hospital
- Mayo Clinic
- St. Paul Heart Clinic
- University of Mississippi Healthcare Center
- St. Luke's Hospital
- Nebraska Heart Institute
- Cooper University Hospital
- New Mexico Heart Institute
- New York University Medical Center
- Columbia University Medical Center
- Mt. Sinai Medical Center
- Summa Health System
- Lindner Clinical Trial Center
- Cleveland Clinic Foundation
- Ohio State University
- Riverside Methodist Hospital
- Geisinger Medical Center
- Harrisburg Hospital / Associated Cardiology
- Allegheny General Hospital
- Presbyterian University Hospital
- Moffitt Heart & Vascular
- Mercy Medical Center West
- St. Thomas Research Institute
- Texas Cardiac Arrhythmia
- St. Lukes Episcopal Hospital
- Intermountain Medical Center
- University of Virginia
- Inova Fairfax Hospital
- Sentara Norfolk General Hospital
- Swedish Medical Center
- Marshfield Clinic
- Na Homolce
- Krankenhaus der Barmherzige Bruder
- Cardiovasculares Centrum Frankfurt - Sankt Katharinen
- Herzzentrum
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Other
WATCHMAN
Warfarin control
Roll-in
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.