AMPLATZER Cardiac Plug Clinical Trial

Last updated: April 2, 2020
Sponsor: Abbott Medical Devices
Overall Status: Completed

Phase

N/A

Condition

Atrial Fibrillation

Cerebral Ischemia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01118299
CL00921
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must have a documented history of paroxysmal, persistent or permanentnonvalvular 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

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 orticagrelor

  • Subject who has an absolute or relative contraindication to aspirin, or warfarin anddabigatran

  • Subject with a New York Heart Association (NYHA) classification equal to IV

  • Subject with an implanted or surgical repair atrial septal defect (ASD) device orpatent 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 atrialfibrillation

  • Subject with a body mass index (BMI) ≥40

  • Subject with a history of acute or recent MI, or unstable angina, or coronary arterybypass graft surgery (within 6 months)

  • Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment

Study Design

Total Participants: 97
Study Start date:
April 26, 2010
Estimated Completion Date:
December 06, 2018

Connect with a study center

  • Huntsville Hospital / Heart Center Research LLC

    Huntsville, Alabama
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Good Samaritan Hospital

    Los Angeles, California 90017
    United States

    Site Not Available

  • Mercy General Hospital/Regional Cardiology Associates

    Sacramento, California 95819
    United States

    Site Not Available

  • University of Colorado Denver

    Aurora, Colorado 80045
    United States

    Site Not Available

  • South Denver Cardiology Associates

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Medical Center of the Rockies

    Loveland, Colorado
    United States

    Site Not Available

  • Florida Heart & Vascular Care at Aventura Hospital and Medical Center

    Aventura, Florida
    United States

    Site Not Available

  • Lakeland Regional Medical Center

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Mount Sinai Medical Center

    Miami, Florida
    United States

    Site Not Available

  • Emory Midtown Hospital and Emory University Hospital

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • St. Joseph's Hospital and Research Institute

    Atlanta, Georgia
    United States

    Site Not Available

  • St. Vincent Heart Center of Indiana

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40506
    United States

    Site Not Available

  • Norton Audubon Hospital

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

  • St. Cloud Hospital/CentraCare Heart and Vascular Clinic

    Saint Cloud, Minnesota 56303
    United States

    Site Not Available

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • St. Cloud Hospital/CentraCare Heart and Vascular Clinic

    St. Cloud, Minnesota
    United States

    Site Not Available

  • HealthEast St. Joseph's Hospital

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • St. Anthony's Medical Center (Metro Heart Group of St. Louis)

    St. Louis, Missouri 63128
    United States

    Site Not Available

  • Good Samaritan Hospital and Bethesda North Hospital

    Cincinnati, Ohio 45220
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Cleveland, Ohio
    United States

    Site Not Available

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Providence Heart and Vascular Institute

    Portland, Oregon 97225
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • York Hospital

    York, Pennsylvania 17405
    United States

    Site Not Available

  • Roper Hospital/PMG Research of Charleston

    Charleston, South Carolina 29401
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • The Heart Hospital Baylor

    Plano, Texas 75093
    United States

    Site Not Available

  • Methodist Texsan Hospital

    San Antonio, Texas 78201
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • Aspirus Heart & Vascular Institute

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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