AMPLATZER AMULET Left Atrial Appendage Occluder Randomized Controlled Trial

Basic eligibility requirements include:

• Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation 
• No rheumatic mitral valvular heart disease
• At high risk of stroke or systemic embolism defined as CHADS2 score >2 or CHADS2-VASC score of >3
• Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
• Deemed by investigator to be suitable for short term warfarin but unable to take long term oral anticoagulation
• Deemed suitable for LAA closure by multidisciplinary team

Basic exclusions include:

• Requires long-term anticoagulation therapy for a condition other than AF
• Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
• Indicated for chronic P2Y12 platelet therapy inhibitor
• Has undergone ASD or PFO repair or has ASD or PFO closure device
• Implanted with mechanical valve prosthesis
• Has contraindications to percutaneous catheterization procedure or cannot accomodate TEE probe
• Stroke or TIA within 90 days prior to randomization or intervention or surgery planned within 60 days after implant procedure
• MI within 90 days of randomization
• NYHA Class IV Congestive Heart Failure
• Symptomatic carotid artery disease
• Resting Heart rate > 110bpm