WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

Completed · Phase 2/Phase 3

Conditions studied: Atrial Fibrillation, Stroke

In brief

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Key facts

Study ID

NCT00129545

Run by

Boston Scientific Corporation

People needed

800

Starts

2005-02-01

Expected to finish

2014-05-01

Last updated by the study team

2015-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)]

You may not qualify if…

• 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%

Where it is running

• Arizona Arrhythmia — Scottsdale, Arizona, United States
• Foundation for Cardiovascular Medicine — La Jolla, California, United States
• Los Angeles Cardiology Associates — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• El Camino Hospital — Mountain View, California, United States
• Orange County Heart — Orange County, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• St. John's Hospital / Pacific Heart — Santa Monica, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Bay Heart Group — Tampa, Florida, United States
• Emory University Midtown Hospital — Atlanta, Georgia, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• North Shore University — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Prairie Education Research Cooperative — Springfield, Illinois, United States
• Baptist Hospital West — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Terrebonne General Medical Center — Houma, Louisiana, United States
• Ochsner Clinic — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Advanced Cardiac Specialists — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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