AMPLATZER Cardiac Plug Clinical Trial

Inclusion Criteria:

- Subject must have a documented history of paroxysmal, persistent or permanent
nonvalvular atrial fibrillation

- Subject must be ≥18 years of age

- Subject must be on warfarin or dabigatran therapy

- Subject must be eligible for long term warfarin or dabigatran therapy

- Subject must have a CHADS(2) score of 2 or greater

Summary of Exclusion Criteria:

- Subject who requires warfarin or dabigatran for a condition other than AF

- Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or
ticagrelor

- Subject who has an absolute or relative contraindication to aspirin, or warfarin and
dabigatran

- Subject with a New York Heart Association (NYHA) classification equal to IV

- Subject with an implanted or surgical repair atrial septal defect (ASD) device or
patent foramen ovale (PFO) device

- Subject with aortic or mitral valve regurgitation of grade 2+ or greater

- Subject with left ventricular ejection fraction (LVEF) ≤30

- Subject with mitral or aortic prosthetic valve

- Subject with a history of hemorrhagic or aneurysmal stroke

- Subject with a history of previous radio frequency (RF) ablation for atrial
fibrillation

- Subject with a body mass index (BMI) ≥40

- Subject with a history of acute or recent MI, or unstable angina, or coronary artery
bypass graft surgery (within 6 months)

- Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment