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 beincluded 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 toenrollment

• 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