AMPLATZER Cardiac Plug Clinical Trial

Amplatzer Cardiac Plug Clinical Trial

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.

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