AMPLATZER Cardiac Plug Clinical Trial

Not Applicable

Completed

Conditions: Peripheral Thromboembolism
Ischemic Stroke
Atrial Fibrillation

Interventions: Device: AMPLATZER Cardiac Plug

Registration Number: NCT01118299

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 97

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device	AMPLATZER Cardiac Plug	AMPLATZER Cardiac Plug
Optimal Medical Therapy (control)	AMPLATZER Cardiac Plug	Warfarin Dabigatran

Primary Outcome Measures

Name	Time	Method
Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only	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	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	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 Outcome Measures

Name	Time	Method

Trial Locations

Locations (18): Emory Midtown Hospital and Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Aspirus Heart & Vascular Institute
🇺🇸
Wausau, Wisconsin, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
St. Cloud Hospital/CentraCare Heart and Vascular Clinic
🇺🇸
Saint Cloud, Minnesota, United States
South Denver Cardiology Associates
🇺🇸
Littleton, Colorado, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
University of Colorado Denver
🇺🇸
Aurora, Colorado, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
St. Joseph's Hospital and Research Institute
🇺🇸
Atlanta, Georgia, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Good Samaritan Hospital
🇺🇸
Los Angeles, California, United States
HealthEast St. Joseph's Hospital
🇺🇸
Saint Paul, Minnesota, United States
Roper Hospital/PMG Research of Charleston
🇺🇸
Charleston, South Carolina, United States
Memorial Hermann Hospital
🇺🇸
Houston, Texas, United States
University of Iowa Hospitals & Clinics
🇺🇸
Iowa City, Iowa, United States
Providence Hospital
🇺🇸
Southfield, Michigan, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States