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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01182441
First received: August 12, 2010
Last updated: September 23, 2013
Last verified: March 2013
  Purpose

This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.

The PREVAIL study was amended to initiate a prospective, non-randomized continued access study titled "Continued Access to PREVAIL (CAP2)" to collect additional information on the safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational sites in the U.S.


Condition Intervention Phase
Atrial Fibrillation
Stroke
Device: WATCHMAN Device
Drug: Warfarin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Primary Endpoints [ Time Frame: 18 month rates ] [ Designated as safety issue: Yes ]
    7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention; Comparison of the composite of stroke, systemic embolism and cardiovascular/unexplained death; Comparison of ischemic stroke and systemic embolism occurring greater than 7 days post randomization.


Secondary Outcome Measures:
  • Predefined Additional Analyses [ Time Frame: 18 month rates and acute procedure rates ] [ Designated as safety issue: Yes ]
    Device and procedure related events; Mortality; New versus experienced operators; Sensitivity analyses for post procedure population, per protocol #1 population and per protocol #2 population


Estimated Enrollment: 475
Study Start Date: November 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182441

  Hide Study Locations
Locations
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 County, 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
St. 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
Columbia University Medical Center
New York, New York, United States, 10032
Mt. Sinai School of Medicine
New York, New York, United States, 10029
New York University Medical Center
New York, New York, United States, 10016
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
Investigators
Principal Investigator: David R. Holmes, M.D. Mayo Clinic
Principal Investigator: Vivek Y. Reddy, M.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01182441     History of Changes
Other Study ID Numbers: CT1004
Study First Received: August 12, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
atrial fibrillation
stroke
TIA
trans ischemic attack
warfarin
Coumadin

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014