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New hope for stroke prevention: device offers alternative to blood thinners for heart patients

NCT ID NCT02928497

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study tested the WATCHMAN device, a small implant that closes off a part of the heart where clots often form, in 481 people with atrial fibrillation who cannot take blood thinners. The goal was to see if the device is safe and effective at reducing stroke risk. Participants received the implant and were followed to track strokes, bleeding, and other complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

481 people

The number who actually took part.

Started

Feb 2017

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The subject is of legal age to participate in the study per the laws of their respective geography. * The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease). * The subject has a calculated CHA2DS2-VASc score of 2 or greater. * The subject is deemed by two study physicians to be unsuitable for oral anticoagulation. * The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant. * The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial. * The subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: * The subject is unable or unwilling to return for required follow-up visits and examinations. * The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation). * The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery). * The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization. * The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event. * The subject has a history of atrial septal repair or has an ASD/PFO device. * The subject has an implanted mechanical valve prosthesis in any position. * The subject suffers from New York Heart Association Class IV Congestive Heart Failure. * The subject has LVEF \< 30%. * The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion). * The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility. * The subject has a life expectancy of less than two years. * The subject has a known or suspected hypercoagulable state.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stroke

Contacts and locations

Locations

  • Aarhus University Hospital

    Aarhus N, DK-8200, Denmark

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Aspirus Heart and Vascular Institute - Research and Education

    Wausau, Wisconsin, 54401, United States

  • Aultman Hospital

    Canton, Ohio, 44710, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Bay Area Cardiology Associates

    Tampa, Florida, 33511, United States

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226, United States

  • Billings Clinic

    Billings, Montana, 59101, United States

  • CHI Franciscan Health System

    Tacoma, Washington, 98405, United States

  • Cardioangiologisches Centrum Bethanien

    Frankfurt, Germany

  • Cardiologicum Hamburg Praxis Wandsbek

    Hamburg, Germany

  • Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203, United States

  • Catholic Medical Center

    Manchester, New Hampshire, 03102, United States

  • Cedars - Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centracare Heart and Vascular

    Saint Cloud, Minnesota, 56303, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Edward Hospital

    Naperville, Illinois, 60540, United States

  • Emory University Hospital

    Atlanta, Georgia, 30308, United States

  • Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Fondazione Toscana Gabriele Monasterio

    Massa, Italy

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53215, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Guys and St. Thomas NHS Foundation Trust

    London, United Kingdom

  • HealthEast St. Joseph's Hospital

    Saint Paul, Minnesota, 55102, United States

  • Heart Group at Deaconness Hospital

    Newburgh, Indiana, 47630, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Herzzentrum Universität Leipzig

    Leipzig, Germany

  • Huntsville Hospital

    Huntsville, Alabama, 35801, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec

    Ste-foy, Canada

  • John Radcliffe Hospital

    Oxford, United Kingdom

  • Kansas City Cardiac Arrhythmia Research

    Overland Park, Kansas, 66211, United States

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805, United States

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103, United States

  • Maine Medical Center

    Portland, Maine, 04074, United States

  • Mayo Clinic Foundation

    Rochester, Minnesota, 55905, United States

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Mercy Hospital Medical Center

    West Des Moines, Iowa, 50266, United States

  • Mercy Research

    St Louis, Missouri, 63141, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Na Homolce Hospital

    Prague, 150 30, Czechia

  • North Colorado Medical Center

    Greeley, Colorado, 80631, United States

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801, United States

  • Northwell Health

    Staten Island, New York, 10305, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43214, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, 9300, Belgium

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Ottawa Heart Institute

    Ottawa, Canada

  • PeaceHealth Southwest Medical

    Vancouver, Washington, 98664, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Rigshospitalet Copenhagen

    Copenhagen, 2100, Denmark

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Royal Sussex County Hospital

    Brighton, United Kingdom

  • Royal Victoria Hospital

    Belfast, United Kingdom

  • Saint Thomas Health

    Nashville, Tennessee, 37205, United States

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Scripps Memorial Hospital

    La Jolla, California, 10666, United States

  • Sharpe Chula Vista Medical Center

    San Diego, California, 92121, United States

  • Southcoast Physicians Group

    Fall River, Massachusetts, 02720, United States

  • St. Anthony Hospital

    Lakewood, Colorado, 80228, United States

  • St. Antonius Ziekenhuis

    Nieuwegein, Netherlands

  • St. Barnabas Medical Center

    Newark, New Jersey, 07112, United States

  • St. John's Health Center

    Santa Monica, California, 90404, United States

  • St. John's Hospital

    Springfield, Illinois, 62769, United States

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • St. Vincent's Hospital

    Indianapolis, Indiana, 46290, United States

  • St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

    Erfurt, Germany

  • Summa Health System

    Akron, Ohio, 44304, United States

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Brompton Hospital

    London, United Kingdom

  • The Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • The Valley Hospital

    Ridgewood, New Jersey, 07450, United States

  • UPMC Heart and Vascular Institute Harrisburg

    Harrisburg, Pennsylvania, 17043, United States

  • Union Memorial Hospital

    Baltimore, Maryland, 21218, United States

  • Universitaetsklinikum Dusseldorf

    Düsseldorf, Germany

  • University of Texas Houston Health Science Center

    The Woodlands, Texas, 77384, United States

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908, United States

  • Vancouver General Hospital

    Vancouver, Canada

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • York Hospital

    York, Pennsylvania, 17403, United States

  • ZNA Middelheim

    Antwerp, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.