AMPLATZER Cardiac Plug Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Amplatzer Cardiac Plug Clinical Trial

Conditions
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Atrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism

Intervention / Treatment
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* Device: AMPLATZER Cardiac Plug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>AMPLATZER Cardiac Plug | Device: AMPLATZER Cardiac Plug<br>* AMPLATZER Cardiac Plug is a percutaneous transcatheter device<br>|
| Active Comparator: Optimal Medical Therapy (control)<br>Warfarin Dabigatran | Device: AMPLATZER Cardiac Plug<br>* AMPLATZER Cardiac Plug is a percutaneous transcatheter device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only | An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol. | From Randomization to Discharge Visit | 
| Long-term Safety - Device Arm Only | All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. | Randomization to 2 year follow-up | 
| Effectiveness Endpoint - Device Arm Only | Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. | Randomization through 2 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACP, Atrial Fibrillation, AF, A Fib, Stroke, Coumadin, Warfarin, Dabigatran, Pradaxa, Blood thinning medication, Left atrial appendage, LAA