WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

Inclusion Criteria:

• Male or female, ≥ 18 years of age
• The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for men and 3 or greater for women

Exclusion Criteria:

• The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction
• The subject is contraindicated or allergic to oral anticoagulation medication and/or aspirin
• The subject is indicated for chronic P2Y12 platelet inhibitor therapy
• The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant
• The subject had a prior stroke) or transient ischemic attack within the 30 days prior to enrollment
• The subject had a prior major bleeding event per ISTH definition within the 30 days prior to randomization, has an active bleed
• The subject has a reversible cause of AF or transient AF
• The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment
• The subject has a history of atrial septal repair or has an ASD/PFO device
• The subject has a known contraindication to TEE
• The subject has a cardiac tumor, signs/symptoms of acute or chronic pericarditis and has an active infection
• The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
• Transthoracic Echo Exclusion Criteria:
• .1. The subject has LVEF < 30%
• .2. The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm
• .3. The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm
• .4. The subject has significant mitral valve stenosis (i.e., MV area <1.5 cm2)