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NCT05836987From ClinicalTrials.govRecruiting

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

  • Atrial Fibrillation

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Johns Hopkins University
Enrolment target
5,350
Started
13 July 2023
Main results due
31 July 2029
Study sites
93
Registry updated
29 September 2026

Can you take part?

  • Ages 22 years to 85 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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 1-5 for men and 2-5 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 daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration. Use of low-dose aspirin is permitted.
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 a cardiac monitor performed within 90 days prior to randomization.
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 ECG-documented, sustained atrial flutter that has not been treated with ablation (participants with atrial flutter who 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)

What this study is about

In the sponsor’s own words, from the registry.

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

Study sites(93)

  • Banner University

    Phoenix, Arizona, United States

    Recruiting

  • University of Southern California - Keck School of Medicine

    Los Angeles, California, United States

    Recruiting

  • University of California Los Angeles (UCLA Health)

    Los Angeles, California, United States

    Recruiting

  • UC Davis Health

    Sacramento, California, United States

    Recruiting

  • Scripps Health

    San Diego, California, United States

    Recruiting

  • Kaiser Permanente

    San Francisco, California, United States

    Not yet recruiting

  • Stanford University

    Stanford, California, United States

    Recruiting

  • University of Colorado

    Aurora, Colorado, United States

    Recruiting

  • South Denver Cardiology Associates, P.C.

    Littleton, Colorado, United States

    Recruiting

  • St. Elizabeth's Medical Center

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

    Recruiting

  • Medical Faculty Associates George Washington University

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

    Withdrawn

  • BayCare Health Systems

    Clearwater, Florida, United States

    Recruiting

  • University of Florida

    Gainesville, Florida, United States

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, United States

    Recruiting

  • University of Miami - Leonard S. Miller SOM

    Miami, Florida, United States

    Recruiting

  • Sarasota Memorial Health Care System

    Sarasota, Florida, United States

    Active, not recruiting

  • Cleveland Clinic Florida

    Stuart, Florida, United States

    Withdrawn

  • Baycare Health Systems Clearwater

    Winter Haven, Florida, United States

    Recruiting

  • Emory University

    Atlanta, Georgia, United States

    Recruiting

  • Georgia Arrhythmia Consultants and Research Institute

    Warner Robins, Georgia, United States

    Recruiting

  • University of Illinois Chicago

    Chicago, Illinois, United States

    Recruiting

  • Northwestern University

    Chicago, Illinois, United States

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, United States

    Recruiting

  • University of Chicago

    Chicago, Illinois, United States

    Recruiting

  • Loyola University Chicago

    Chicago, Illinois, United States

    Recruiting

  • Alexian Brothers Health System

    Elk Grove Village, Illinois, United States

    Recruiting

  • NorthShore University HealthSystem

    Evanston, Illinois, United States

    Recruiting

  • Midwest Cardiovascular Institute

    Naperville, Illinois, United States

    Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana, United States

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States

    Recruiting

  • Maine Medical Partners MaineHealth Cardiology

    Scarborough, Maine, United States

    Recruiting

  • Johns Hopkins Univeristy

    Baltimore, Maryland, United States

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, United States

    Recruiting

  • Mass General Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, United States

    Recruiting

  • BMC - Brighton

    Boston, Massachusetts, United States

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

    Recruiting

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, United States

    Recruiting

  • UMass Chan Medical School

    Worcester, Massachusetts, United States

    Active, not recruiting

  • Henry Ford Health

    Detroit, Michigan, United States

    Recruiting

  • Corewell Health (Former Spectrum Health)

    Grand Rapids, Michigan, United States

    Recruiting

  • Trinity Health Grand Rapids/Mercy Health

    Grand Rapids, Michigan, United States

    Recruiting

  • William Beaumont Hospital

    Royal Oak, Michigan, United States

    Recruiting

  • Trinity Health Michigan Heart - Ann Arbor

    Ypsilanti, Michigan, United States

    Recruiting

  • Essentia Health The Duluth Clinic

    Duluth, Minnesota, United States

    Active, not recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, United States

    Recruiting

  • Hennepin Healthcare Research Institute

    Minneapolis, Minnesota, United States

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, United States

    Recruiting

  • University Health Truman Medical Center

    Kansas City, Missouri, United States

    Withdrawn

  • Washington University School of Medicine

    St Louis, Missouri, United States

    Recruiting

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey, United States

    Recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, United States

    Recruiting

  • Rutgers, the State University of New Jersey

    Piscataway, New Jersey, United States

    Recruiting

  • The Valley Hospital, Inc.

    Ridgewood, New Jersey, United States

    Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, United States

    Recruiting

  • Presbyterian Healthcare Services

    Albuquerque, New Mexico, United States

    Active, not recruiting

  • University at Buffalo

    Buffalo, New York, United States

    Recruiting

  • NYU Langone Health

    New York, New York, United States

    Recruiting

  • Columbia University Medical Center

    New York, New York, United States

    Recruiting

Showing 60 of 93 sites — filter to narrow it down. 84 of the 93 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05836987. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation | Trialion