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Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial).
Journal article

Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial).

  • Lakkireddy D Kansas City Heart Rhythm Institute, Kansas City, KS. Electronic address: dlakkireddy@hcahealthcare.com.
  • Windecker S Inselspital, Bern University Hospital, University Hospital of Bern, Bern, Switzerland.
  • Thaler D Tufts Medical Center, Boston, MA.
  • Søndergaard L Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  • Carroll J University of Colorado, Aurora, CO.
  • Gold MR Medical University of South Carolina, Charleston, SC.
  • Guo H Abbott, Plymouth, MN.
  • Brunner KJ Abbott, Plymouth, MN.
  • Hermiller JB St. Vincent Medical Group, Indianapolis, IN.
  • Diener HC University Hospital Essen, Essen, Germany.
  • Schmidt B Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
  • MacDonald L South Denver Cardiology Associates, Littleton, CO.
  • Mansour M Massachusetts General Hospital, Boston, MA.
  • Maini B Tenet Florida & Department of Cardiovascular Diseases, Florida Atlantic University, Boca Raton, FL.
  • Levine J St. Francis Hospital, Roslyn, NY.
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  • 2019-03-05
Published in:
  • American heart journal. - 2019
Anticoagulants
Atrial Fibrillation
Cardiac Catheterization
Cardiac Surgical Procedures
Cause of Death
Fibrinolytic Agents
Hemorrhage
Humans
Postoperative Complications
Prospective Studies
Prosthesis Design
Risk Factors
Septal Occluder Device
Stroke
English The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.
Language
  • English
Open access status
closed
Identifiers
Persistent URL
https://folia.unifr.ch/global/documents/157124
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