Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
NCT ID: NCT02928497
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
481 participants
INTERVENTIONAL
2017-02-06
2025-09-23
Brief Summary
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Detailed Description
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Subjects will be randomized in a ratio of 2 Device to 1 Control to receive the WATCHMAN LAA closure device (Device) or the control treatment of single antiplatelet medication or no medication at the discretion of the study physician (Control). All randomized subjects will follow the protocol required tests and assessments at each scheduled follow-up visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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WATCHMAN (Device)
WATCHMAN LAAC Device implant including modified post-implant drug regimen.
WATCHMAN LAAC Device Implant
WATCHMAN LAAC Implant
Control
Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.
Single Antiplatelet Therapy or No Therapy (Control)
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
Interventions
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WATCHMAN LAAC Device Implant
WATCHMAN LAAC Implant
Single Antiplatelet Therapy or No Therapy (Control)
Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Jacqueline Saw, MD
Role: PRINCIPAL_INVESTIGATOR
Vancouver General Hospital
Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Maurice Buchbinder, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Scripps Memorial Hospital
La Jolla, California, United States
Cedars - Sinai Medical Center
Los Angeles, California, United States
Sharpe Chula Vista Medical Center
San Diego, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
St. John's Health Center
Santa Monica, California, United States
North Colorado Medical Center
Greeley, Colorado, United States
St. Anthony Hospital
Lakewood, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Delray Medical Center
Delray Beach, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Bay Area Cardiology Associates
Tampa, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Heart Group at Deaconness Hospital
Newburgh, Indiana, United States
Mercy Hospital Medical Center
West Des Moines, Iowa, United States
Kansas City Cardiac Arrhythmia Research
Overland Park, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Southcoast Physicians Group
Fall River, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic Foundation
Rochester, Minnesota, United States
Centracare Heart and Vascular
Saint Cloud, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Mercy Research
St Louis, Missouri, United States
Billings Clinic
Billings, Montana, United States
The Nebraska Medical Center
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
St. Barnabas Medical Center
Newark, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
Mount Sinai Medical Center
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Northwell Health
Staten Island, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Aultman Hospital
Canton, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health Sciences University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC Heart and Vascular Institute Harrisburg
Harrisburg, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Saint Thomas Health
Nashville, Tennessee, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
University of Texas Houston Health Science Center
The Woodlands, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
CHI Franciscan Health System
Tacoma, Washington, United States
PeaceHealth Southwest Medical
Vancouver, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Aspirus Heart and Vascular Institute - Research and Education
Wausau, Wisconsin, United States
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
Ottawa Heart Institute
Ottawa, , Canada
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste-foy, , Canada
Vancouver General Hospital
Vancouver, , Canada
Na Homolce Hospital
Prague, , Czechia
Aarhus University Hospital
Aarhus N, , Denmark
Rigshospitalet Copenhagen
Copenhagen, , Denmark
Universitaetsklinikum Dusseldorf
Düsseldorf, , Germany
St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH
Erfurt, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Cardiologicum Hamburg Praxis Wandsbek
Hamburg, , Germany
Herzzentrum Universität Leipzig
Leipzig, , Germany
Fondazione Toscana Gabriele Monasterio
Massa, , Italy
Medisch Spectrum Twente
Enschede, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Royal Victoria Hospital
Belfast, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Guys and St. Thomas NHS Foundation Trust
London, , United Kingdom
The Brompton Hospital
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Alomar M, Fradley MG. Electrophysiology Translational Considerations in Cardio-Oncology: QT and Beyond. J Cardiovasc Transl Res. 2020 Jun;13(3):390-401. doi: 10.1007/s12265-019-09924-y. Epub 2019 Oct 31.
Other Identifiers
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S2317
Identifier Type: -
Identifier Source: org_study_id
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