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Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01182441
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Device: WATCHMAN Device Drug: Warfarin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy
Actual Study Start Date : November 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: WATCHMAN
Subjects assigned to receive the WATCHMAN device.
Device: WATCHMAN Device
WATCHMAN Left Atrial Appendage Closure Technology

Active Comparator: Warfarin
Subjects assigned to warfarin therapy.
Drug: Warfarin
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Other Name: Coumadin

Primary Outcome Measures :
  1. Primary Safety Endpoint (Device Group Only) [ Time Frame: 7-Day ]
    7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.

  2. Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown) [ Time Frame: 18 month rate ]
    The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.

  3. Composite of Ischemic Stroke or Systemic Embolism [ Time Frame: Day 8 to 18-months ]
    Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Paroxysmal, persistent or permanent non-valvular AF
  • Eligible for long-term warfarin therapy
  • Eligible to come off warfarin therapy
  • Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:

    • Female age 75 or older
    • Baseline LVEF ≥ 30 and < 35%
    • Aged 65-74 and has diabetes or coronary artery disease
    • Aged 65 or greater and has congestive heart failure

Key Exclusion Criteria:

  • Contraindicated/allergic to aspirin
  • Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
  • History of atrial septal repair or has an ASD/PFO device
  • Implanted mechanical valve prosthesis
  • NYHA Class IV CHF
  • Resting heart rate > 110 bpm
  • Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

  • LVEF < 30%
  • Existing pericardial effusion > 2mm
  • High risk PFO
  • Significant mitral valve stenosis
  • Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
  • Cardiac tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01182441

  Hide Study Locations
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United States, Arizona
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Arizona Heart Rhythm Research Center
Scottsdale, Arizona, United States, 85251
United States, California
Foundation for Cardiovascular Medicine
La Jolla, California, United States, 92037
Scripps Green
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Orange County Heart
Orange, California, United States, 92868
St. John's Hospital / Pacific Heart
Santa Monica, California, United States, 90404
United States, Florida
Zasa Clinical Research
Atlantis, Florida, United States, 33462
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
United States, Illinois
North Shore University
Evanston, Illinois, United States, 60201
United States, Iowa
Iowa Heart Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Mississippi
Cardiology Associates of N. Mississippi
Tupelo, Mississippi, United States, 38801
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
St. John's Mercy
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Bryan LGH
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Englewood Hospital and Medical Center
Englewood, New Jersey, United States, 07631
United States, New York
New York University Medical Center
New York, New York, United States, 10016
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Moffitt Heart & Vascular
Wormleysburg, Pennsylvania, United States, 17043
United States, Tennessee
St. Thomas Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705
Baylor Research Institute
Dallas, Texas, United States, 75226
Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107
United States, Vermont
Fletcher Allen
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
United States, Wisconsin
St. Luke's Hospital
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boston Scientific Corporation Identifier: NCT01182441     History of Changes
Other Study ID Numbers: CT1004
First Posted: August 16, 2010    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Boston Scientific Corporation:
atrial fibrillation
trans ischemic attack
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes