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NCT02928497

Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Official title: Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

481

Start Date

2017-02-06

Completion Date

2025-09-23

Last Updated

2026-08-25

Healthy Volunteers

Conditions

Stroke

Interventions

DEVICE

WATCHMAN LAAC Device Implant

WATCHMAN LAAC Implant

DRUG

Single Antiplatelet Therapy or No Therapy (Control)

Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.

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.

Locations (92)

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