Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

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