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

NCT02928497 | Completed DMC FDA Device

• 1 other identifier: S2317
• Study Type: interventional
• Target: 481
• Locations: 9 countries
• Sites: 92

Brief 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.

Conditions

Stroke

Keywords

Non-valvular atrial fibrillation; Left atrial appendage

Outcome Measures

Primary Outcomes (2)

• Primary 7-Day Device/Procedural Safety Endpoint

  The primary safety endpoint is the 7-day combined rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.

  7 days

• Primary Efficacy Endpoint - time to first event of ischemic stroke or systemic embolism.

  The primary efficacy endpoint is the comparison of time to first event of ischemic stroke and systemic embolism.

  5 years

Secondary Outcomes (2)

• Secondary Endpoint - Composite of All Stroke and Cardiovascular or Unknown Death

  5 years

• Secondary Endpoint - Major Bleeding

  5 years

Study Arms (2)

WATCHMAN (Device)

EXPERIMENTAL

WATCHMAN LAAC Device implant including modified post-implant drug regimen.

Device: WATCHMAN LAAC Device Implant

Control

ACTIVE COMPARATOR

Single antiplatelet therapy or no therapy (Control) at the discretion of the study physician for the duration of the trial.

Drug: Single Antiplatelet Therapy or No Therapy (Control)

Interventions

WATCHMAN LAAC Device Implant DEVICE

WATCHMAN LAAC Implant

WATCHMAN (Device)

Single Antiplatelet Therapy or No Therapy (Control) DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (92)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Huntsville Hospital

Huntsville, Alabama, 35801, United States

Location

Arizona Arrhythmia Research Center

Phoenix, Arizona, 85016, United States

Location

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Scripps Memorial Hospital

La Jolla, California, 10666, United States

Location

Cedars - Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sharpe Chula Vista Medical Center

San Diego, California, 92121, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

St. John's Health Center

Santa Monica, California, 90404, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Washington Hospital Center

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

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Bay Area Cardiology Associates

Tampa, Florida, 33511, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46290, United States

Location

Heart Group at Deaconness Hospital

Newburgh, Indiana, 47630, United States

Location

Mercy Hospital Medical Center

West Des Moines, Iowa, 50266, United States

Location

Kansas City Cardiac Arrhythmia Research

Overland Park, Kansas, 66211, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Maine Medical Center

Portland, Maine, 04074, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

Centracare Heart and Vascular

Saint Cloud, Minnesota, 56303, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Mercy Research

St Louis, Missouri, 63141, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

The Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

St. Barnabas Medical Center

Newark, New Jersey, 07112, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Northwell Health

Staten Island, New York, 10305, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Summa Health System

Akron, Ohio, 44304, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

UPMC Heart and Vascular Institute Harrisburg

Harrisburg, Pennsylvania, 17043, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

York Hospital

York, Pennsylvania, 17403, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

University of Texas Houston Health Science Center

The Woodlands, Texas, 77384, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

CHI Franciscan Health System

Tacoma, Washington, 98405, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, 98664, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53215, United States

Location

Aspirus Heart and Vascular Institute - Research and Education

Wausau, Wisconsin, 54401, United States

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Ottawa Heart Institute

Ottawa, Canada

Location

Institut universitaire de Cardiologie et de Pneumologie de Quebec

Ste-foy, Canada

Location

Vancouver General Hospital

Vancouver, Canada

Location

Na Homolce Hospital

Prague, 150 30, Czechia

Location

Aarhus University Hospital

Aarhus N, DK-8200, Denmark

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Universitaetsklinikum Dusseldorf

Düsseldorf, Germany

Location

St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH

Erfurt, Germany

Location

Cardioangiologisches Centrum Bethanien

Frankfurt, Germany

Location

Cardiologicum Hamburg Praxis Wandsbek

Hamburg, Germany

Location

Herzzentrum Universität Leipzig

Leipzig, Germany

Location

Fondazione Toscana Gabriele Monasterio

Massa, Italy

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Royal Victoria Hospital

Belfast, United Kingdom

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Guys and St. Thomas NHS Foundation Trust

London, United Kingdom

Location

The Brompton Hospital

London, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31673900 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jacqueline Saw, MD

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Maurice Buchbinder, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 10, 2016
• Study Start: February 6, 2017
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); DK (2); DE (5); GB (5); CA (3); NL (2); US (71); CZ (1); IT (1)