AMPLATZER Cardiac Plug Clinical Trial

Abbott

Status

Completed

Conditions

Ischemic Stroke

Atrial Fibrillation

Peripheral Thromboembolism

Treatments

Device: AMPLATZER Cardiac Plug

Study type

Interventional

Funder types

Industry

Identifiers

NCT01118299

CL00921

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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