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


Phase 2/3 Results

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%