Could a single pill replace two after heart implant? major trial seeks safer stroke prevention

NCT ID NCT06521463

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

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 5 times

Summary

This study tests whether people with atrial fibrillation who receive a WATCHMAN FLX Pro device can safely take just one blood thinner or aspirin instead of the usual two-drug plan. About 1,857 participants are being followed for six months to compare rates of death, stroke, major bleeding, and other events. The goal is to find a simpler, safer way to prevent strokes after the implant.

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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

1,857 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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: * Subject is of legal age to participate in the study per the laws of their respective geography. * Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use. * Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms. * 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: * Subject's device implant procedure was aborted (i.e., failed implant). * Subject has a device margin residual leak \> 0mm at time of implant. * Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization. * Subject has a contraindication to one of the three protocol defined drug regimens. * Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy. * Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D. * Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis. * Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging. * Subject has Modified Rankin Score of ≥ 3 at baseline. * Subject has left ventricular ejection fraction (LVEF) \< 30%. * Subject with known amyloid cardiomyopathy. * Platelet count ≤ 100,000 x 109/L. * Subject has an estimated glomerular filtration rate (eGFR) \< 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis. * Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization. * Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization. * Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.). * Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or 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. * Subject has an active bleed. * Subject has a cardiac tumor. * Subject has signs/symptoms of acute or chronic pericarditis. * Subject has an active infection. * There is evidence of tamponade physiology. * Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization. * Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. * Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study. * Subject has a documented life expectancy of less than 12 months.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Bleeding Stroke

Contacts and locations

Locations

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States
Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
Baptist Medical Center

Jacksonville, Florida, 32207, United States
Bellin Health

Green Bay, Wisconsin, 54305, United States
Bethesda North Hospital-Hospital

Cincinnati, Ohio, 45242, United States
Cardiology Associates Medical Group

Ventura, California, 93003, United States
Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States
Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States
Charlton Memorial

Fall River, Massachusetts, 02720, United States
Chippenham & Johnston-Willis Hospital

Richmond, Virginia, 23235, United States
Christus Trinity Mother Frances Health System-Hospital

Tyler, Texas, 75702, United States
Colorado Heart and Vascular PC

Lakewood, Colorado, 80401, United States
Community Heart and Vascular Hospita

Indianapolis, Indiana, 46250, United States
Cooper Hospital - University Medical Center

Camden, New Jersey, 08103, United States
Corewell Health

Grand Rapids, Michigan, 49503, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Evanston Hospital

Evanston, Illinois, 60201, United States
Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States
Georgia Arrhythmia Consultants

Macon, Georgia, 31201, United States
Grandview Medical Center

Birmingham, Alabama, 35243, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
HonorHealth Heart Group - Shea

Scottsdale, Arizona, 85258, United States
John Muir Medical Center

Concord, California, 94520, United States
Kaleida Health

Buffalo, New York, 14203, United States
Kootenai Medical Center

Coeur d'Alene, Idaho, 83814, United States
Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97227, United States
Loma Linda University Medical Center

Loma Linda, California, 92354, United States
Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States
Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States
M Health Fairview St John's Hospital

Maplewood, Minnesota, 55109, United States
MUSC Health Columbia Medical Center Downtown

Columbia, South Carolina, 29204, United States
Mayo Clinic Foundation

Rochester, Minnesota, 55902, United States
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Memorial Health University Medical Center

Savannah, Georgia, 31405, United States
Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States
Mercy Hospital Medical Center

Des Moines, Iowa, 50266, United States
Methodist Hospital

San Antonio, Texas, 78229, United States
Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States
Mills Peninsula Health Services

Burlingame, California, 94010, United States
Monongalia General Hospital

Morgantown, West Virginia, 26505, United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Naples Community Hospital

Naples, Florida, 34102, United States
New York University Medical Center

New York, New York, 10016, United States
North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States
Northwell Health

Bay Shore, New York, 11706, United States
Norton Hospital

Louisville, Kentucky, 40202, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Orion Medical

Houston, Texas, 77034, United States
Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States
PIMA Heart and Vascular

Tucson, Arizona, 85712, United States
Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States
Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States
Prisma Health

Columbia, South Carolina, 29203, United States
Rex Hospital

Raleigh, North Carolina, 27607, United States
Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Scripps Memorial Hospital

La Jolla, California, 92037, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
St. John's Health Center

Los Angeles, California, 90404, United States
St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States
St. Luke's Boise Medical Center

Boise, Idaho, 83712, United States
St. Luke's Hospital

St Louis, Missouri, 63141, United States
St. Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States
St. Mark's Hospital

Salt Lake City, Utah, 84124, United States
St. Thomas Heart

Nashville, Tennessee, 37203, United States
Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States
Straub Medical Center

Honolulu, Hawaii, 96813, United States
Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States
Trident Medical Center

Charleston, South Carolina, 29406, United States
University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States
University of Alabama Birmingham

Birmingham, Alabama, 35233, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kansas

Kansas City, Kansas, 66160, United States
University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Washington Medical Center

Seattle, Washington, 98195, United States
Valley Hospital

Paramus, New Jersey, 07652, United States
Virtua Health

Marlton, New Jersey, 08053, United States
Wake Medical Center

Raleigh, North Carolina, 27610, United States
Washington Hospital

Washington D.C., District of Columbia, 20010, United States
Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

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