Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy "PREVAIL"

Active, not recruiting

Phase 3 Results N/A

Eligibility Criteria

Key

Inclusion Criteria

- Paroxysmal, persistent or permanent non-valvular AF
- Eligible for long-term warfarin therapy
- Eligible to come off warfarin therapy
- Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:
- Female age 75 or older
- Baseline LVEF ≥ 30 and < 35%
- Aged 65-74 and has diabetes or coronary artery disease
- Aged 65 or greater and has congestive heart failure
Key

Exclusion Criteria

- Contraindicated/allergic to aspirin
- Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
- History of atrial septal repair or has an ASD/PFO device
- Implanted mechanical valve prosthesis
- NYHA Class IV CHF
- Resting heart rate > 110 bpm
- Participated previously in the PROTECT AF or CAP Registry studies
Key Echo Exclusion Criteria:
- LVEF < 30%
- Existing pericardial effusion > 2mm
- High risk PFO
- Significant mitral valve stenosis
- Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
- Cardiac tumor