AMPLATZER Cardiac Plug Clinical Trial



Status:Completed
Conditions:Atrial Fibrillation, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:April 26, 2010
End Date:December 6, 2018

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Amplatzer Cardiac Plug Clinical Trial

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.


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
We found this trial at
18
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Atlanta, GA
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Charleston, South Carolina
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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Grand Rapids, Michigan 49503
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Houston, Texas 77030
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Littleton, Colorado 80120
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Los Angeles, California 90017
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Saint Cloud, MN
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Saint Paul, Minnesota 55102
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16001 W 9 Mile Rd
Southfield, Michigan 48075
(248) 849-3000
Providence Hospital St. John Providence Health System is comprised of five hospitals plus more than...
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Wausau, Wisconsin 54401
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York, Pennsylvania 17315
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York, PA
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