Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)

Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients

This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.

Key Inclusion Criteria:

• Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
• Eligible for long-term Warfarin therapy;
• Eligible to come off Warfarin therapy if the LAA is sealed
• Calculated CHADS2 score of 1 or greater

Key Exclusion Criteria:

• New York Heart Association Class IV Congestive Heart Failure
• Recent MI (within 3 months)
• ASD and/or atrial septal repair or closure device
• Resting heart rate >110 bpm
• Has an implanted mechanical valve prosthesis
• Left atrial appendage is obliterated
• Has undergone heart transplantation
• Has symptomatic carotid disease
• Contraindicated for aspirin
• LVEF < 30%
• Cardiac Tumor