Study Results
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View full resultsBasic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2010-04-26
2018-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Device
AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Optimal Medical Therapy (control)
Warfarin Dabigatran
AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Interventions
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AMPLATZER Cardiac Plug
AMPLATZER Cardiac Plug is a percutaneous transcatheter device
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Good Samaritan Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado Denver
Aurora, Colorado, United States
South Denver Cardiology Associates
Littleton, Colorado, United States
Emory Midtown Hospital and Emory University Hospital
Atlanta, Georgia, United States
St. Joseph's Hospital and Research Institute
Atlanta, Georgia, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Providence Hospital
Southfield, Michigan, United States
St. Cloud Hospital/CentraCare Heart and Vascular Clinic
Saint Cloud, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Roper Hospital/PMG Research of Charleston
Charleston, South Carolina, United States
Memorial Hermann Hospital
Houston, Texas, United States
Aspirus Heart & Vascular Institute
Wausau, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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What is Atrial Fibrillation - Fact Sheet
Overview of Atrial Fibrillation
Let's Talk about Stroke, TIA and Warning Signs - Fact Sheet
Other Identifiers
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CL00921
Identifier Type: -
Identifier Source: org_study_id
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