Amplatzer Cardiac Plug Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 97
- Locations
- 35
- Primary Endpoint
- Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Outcomes
Primary Outcomes
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
Time Frame: From Randomization to Discharge Visit
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.
Effectiveness Endpoint - Device Arm Only
Time Frame: Randomization through 2 year follow up
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.
Long-term Safety - Device Arm Only
Time Frame: Randomization to 2 year follow-up
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.
Secondary Outcomes
No secondary outcomes reported