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Clinical trialNCT01182441CompletedPhase 3Interventional

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

SponsorBoston Scientific CorporationEnrollment407Atrial FibrillationStroke
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

41 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mercy Gilbert Medical Center

    Gilbert, Arizona, United States

  • Arizona Heart Rhythm Research Center

    Scottsdale, Arizona, United States

  • Foundation for Cardiovascular Medicine

    La Jolla, California, United States

  • Scripps Green

    La Jolla, California, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, United States

  • Orange County Heart

    Orange, California, United States

  • St. John'S Hospital / Pacific Heart

    Santa Monica, California, United States

  • Zasa Clinical Research

    Atlantis, Florida, United States

  • Baptist Hospital of Miami

    Miami, Florida, United States

  • Florida Hospital

    Orlando, Florida, United States

  • Emory University

    Atlanta, Georgia, United States

  • North Shore University

    Evanston, Illinois, United States

  • Iowa Heart Center

    Des Moines, Iowa, United States

  • Central Baptist Hospital

    Lexington, Kentucky, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

  • Lahey Clinic

    Burlington, Massachusetts, United States

  • University of Michigan Medical Center

    Ann Arbor, Michigan, United States

  • William Beaumont

    Royal Oak, Michigan, United States

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, United States

  • Mayo Clinic

    Rochester, Minnesota, United States

  • Cardiology Associates of N. Mississippi

    Tupelo, Mississippi, United States

  • St. Luke'S Hospital

    Kansas City, Missouri, United States

  • St. John'S Mercy

    St Louis, Missouri, United States

  • Bryan Lgh

    Lincoln, Nebraska, United States

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, United States

  • Columbia University Medical Center

    New York, New York, United States

  • Mt. Sinai School of Medicine

    New York, New York, United States

  • New York University Medical Center

    New York, New York, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, United States

  • Lindner Clinical Trial Center

    Cincinnati, Ohio, United States

  • Cleveland Clinic

    Cleveland, Ohio, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • Moffitt Heart & Vascular

    Wormleysburg, Pennsylvania, United States

  • St. Thomas Research Institute

    Nashville, Tennessee, United States

  • Texas Cardiac Arrhythmia

    Austin, Texas, United States

  • Baylor Research Institute

    Dallas, Texas, United States

  • Methodist Hospital

    Houston, Texas, United States

  • Intermountain Medical Center

    Salt Lake City, Utah, United States

  • Fletcher Allen

    Burlington, Vermont, United States

  • Swedish Medical Center

    Seattle, Washington, United States

1 more site on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2010
Primary completion
31 Jan 2013
Completion
30 Nov 2017
Last update posted
26 Jul 2018
Registered enrollment
407
Registry id
NCT01182441

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.