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Smartwatch study could change how millions take blood thinners

NCT ID NCT05836987

Disease control Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This study tests if people with atrial fibrillation (an irregular heartbeat) can use a smartwatch to decide when to take blood thinners, instead of taking them every day. About 5,350 adults with a low-to-moderate stroke risk will be randomly assigned to either standard daily blood thinners or smartwatch-guided, short-term use. The goal is to see if the smartwatch approach is just as good at preventing strokes while causing fewer bleeding problems.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 5,350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

22 to 85 years

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: 1. 22-85 years of age. 2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated. 3. History of non-permanent atrial fibrillation. 4. CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%. 5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study. 6. Willing and able to comply with the protocol, including: * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan * Be willing to wear the smart watch for the suggested minimum of 14 hours a day * Expected to be within cellular service range at least 80% of the time 7. Willing and able to discontinue DOAC 8. The participant is willing and able to provide informed consent. Exclusion Criteria: 1. Valvular or permanent atrial fibrillation. 2. Current treatment with warfarin and unwilling or unable to take a DOAC. 3. The participant is a woman who is pregnant or nursing. 4. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration. 5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment. 6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months. 7. Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI. 8. Ablation for AF within the last 2 months. 9. Prior or anticipated left atrial appendage occlusion or ligation. 10. Mechanical prosthetic valve(s) or severe valve disease. 11. Hypertrophic cardiomyopathy. 12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve). 13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion. 14. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial. 15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn. 16. The participant has a tremor on their ipsilateral side that the AFSW may be worn. 17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). 18. Known hypersensitivity or contraindication to direct oral anticoagulants. 19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack. 20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF. 21. \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring. 22. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment). 23. Stage 4 or 5 chronic kidney disease. 24. Conditions associated with an increased risk of bleeding: * Major surgery in the previous month * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks. * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days * Hemorrhagic disorder or bleeding diathesis * Need for anticoagulant treatment for disorders other than AF * Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Ischemic Stroke paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Heart and Vascular Institute of Hunterdon

    RECRUITING

    Flemington, New Jersey, 08822, United States

  • Alexian Brothers Health System

    RECRUITING

    Elk Grove Village, Illinois, 60007, United States

  • Allegheny Singer Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension St. Vincent

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • BMC - Brighton

    RECRUITING

    Boston, Massachusetts, 02135, United States

  • Banner University

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • BayCare Health Systems

    RECRUITING

    Clearwater, Florida, 33759, United States

  • Baycare Health Systems Clearwater

    RECRUITING

    Winter Haven, Florida, 33881, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cardiology Consultants of Philadelphia

    NOT_YET_RECRUITING

    Paoli, Pennsylvania, 19301, United States

  • Cleveland Clinic Florida

    WITHDRAWN

    Stuart, Florida, 34994, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Corewell Health (Former Spectrum Health)

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30332, United States

  • Essentia Health The Duluth Clinic

    ACTIVE_NOT_RECRUITING

    Duluth, Minnesota, 55812, United States

  • Georgia Arrhythmia Consultants and Research Institute

    RECRUITING

    Warner Robins, Georgia, 31093, United States

  • Hackensack Meridian Health

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hennepin Healthcare Research Institute

    RECRUITING

    Minneapolis, Minnesota, 55415, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • James River Cardiology

    RECRUITING

    Richmond, Virginia, 23229, United States

  • Johns Hopkins Univeristy

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Kaiser Permanente

    NOT_YET_RECRUITING

    San Francisco, California, 94115, United States

  • Lahey Hospital & Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Loyola University Chicago

    RECRUITING

    Chicago, Illinois, 60660, United States

  • MUSC Health Heart and Vascular

    RECRUITING

    Columbia, South Carolina, 29204, United States

  • Maine Medical Partners MaineHealth Cardiology

    RECRUITING

    Scarborough, Maine, 04074, United States

  • Mass General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical College of Wisconsin Froedtert Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical Faculty Associates George Washington University

    WITHDRAWN

    Washington D.C., District of Columbia, 20037, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Midwest Cardiovascular Institute

    RECRUITING

    Naperville, Illinois, 60540, United States

  • Minneapolis Heart Institute Foundation

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • NewYork Presbyterian - Queens

    RECRUITING

    Queens, New York, 11355, United States

  • NorthShore University HealthSystem

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Penn State Health Medical Group Berks Cardiology

    RECRUITING

    Wyomissing, Pennsylvania, 19610, United States

  • Presbyterian Healthcare Services

    ACTIVE_NOT_RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Rutgers, the State University of New Jersey

    RECRUITING

    Piscataway, New Jersey, 08854, United States

  • Sarasota Memorial Health Care System

    RECRUITING

    Sarasota, Florida, 34236, United States

  • Scripps Health

    RECRUITING

    San Diego, California, 92103, United States

  • South Denver Cardiology Associates, P.C.

    RECRUITING

    Littleton, Colorado, 80120, United States

  • St. Elizabeth's Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20032, United States

  • St. Joseph Medical Center Tacoma

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

  • Staten Island University Hospital-Northwell Health

    RECRUITING

    Staten Island, New York, 10305, United States

  • Stony Brook University

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Texas Cardiac Arrhythmia Research Foundation

    RECRUITING

    Austin, Texas, 78705, United States

  • The Lindner Center for Research and Education at The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • The Valley Hospital, Inc.

    RECRUITING

    Ridgewood, New Jersey, 07450, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19144, United States

  • Trinity Health Grand Rapids/Mercy Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Trinity Health Michigan Heart - Ann Arbor

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UC Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • UMass Chan Medical School

    ACTIVE_NOT_RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University Health Truman Medical Center

    WITHDRAWN

    Kansas City, Missouri, 64108, United States

  • University at Buffalo

    RECRUITING

    Buffalo, New York, 14214, United States

  • University of California Los Angeles (UCLA Health)

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati College of Medicine

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32611, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60607, United States

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami - Leonard S. Miller SOM

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico Health Sciences Center

    RECRUITING

    Albuquerque, New Mexico, 87102, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Southern California - Keck School of Medicine

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53706, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Wake Forest Baptist Health

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Medical College of Cornell University

    RECRUITING

    New York, New York, 10065, United States

  • Westchester Medical Center

    RECRUITING

    Valhalla, New York, 10595, United States

  • White Plains Hospital

    RECRUITING

    White Plains, New York, 10601, United States

  • William Beaumont Hospital

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Wooster Community Hospital

    RECRUITING

    Wooster, Ohio, 44691, United States

More trials for these conditions

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