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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation
• Treatments: Warfarin

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%