- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118299
AMPLATZER Cardiac Plug Clinical Trial
Amplatzer Cardiac Plug Clinical Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, United States, 90017
- Good Samaritan Hospital
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Denver
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Littleton, Colorado, United States, 80120
- South Denver Cardiology Associates
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Georgia
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Atlanta, Georgia, United States, 30308
- Emory Midtown Hospital and Emory University Hospital
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Atlanta, Georgia, United States
- St. Joseph's Hospital and Research Institute
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals & Clinics
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health
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Southfield, Michigan, United States, 48075
- Providence Hospital
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Minnesota
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Saint Cloud, Minnesota, United States, 56303
- St. Cloud Hospital/CentraCare Heart and Vascular Clinic
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Saint Paul, Minnesota, United States, 55102
- HealthEast St. Joseph's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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York, Pennsylvania, United States, 17405
- York Hospital
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South Carolina
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Charleston, South Carolina, United States, 29401
- Roper Hospital/PMG Research of Charleston
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Texas
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Houston, Texas, United States, 77030
- Memorial Hermann Hospital
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Wisconsin
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Wausau, Wisconsin, United States, 54401
- Aspirus Heart & Vascular Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device
AMPLATZER Cardiac Plug
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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Active Comparator: Optimal Medical Therapy (control)
Warfarin Dabigatran
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
From Randomization to Discharge Visit
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Long-term Safety - Device Arm Only
Time Frame: Randomization to 2 year follow-up
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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
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. |
Randomization through 2 year follow up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL00921
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
University Hospital Inselspital, BerneCompletedIschemia | Coronary Artery Disease | Internal Mammary-Coronary Artery Anastomosis | Circulation, CollateralSwitzerland
-
Abbott Medical DevicesRecruitingPFO - Patent Foramen Ovale | VSD - Muscular Ventricular Septal Defect | PIVSD - Post Infarct Muscular Ventricular Septal Defect | ASD - Atrial Septal DefectSpain, Germany, Poland, France, Italy, Netherlands, Switzerland