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RECRUITING Phase 3 ClinicalTrials.gov

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT05836987

Registry updated: 2026-10-14
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Description

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.

Interventions

  • AFSW Guided DOAC (Device)
    The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.
  • Continuous DOAC therapy (Drug)
    DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

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)

Conditions

Atrial Fibrillation

Locations

  • Banner University — Phoenix, Arizona, United States
  • University of Southern California - Keck School of Medicine — Los Angeles, California, United States
  • University of California Los Angeles (UCLA Health) — Los Angeles, California, United States
  • UC Davis Health — Sacramento, California, United States
  • Scripps Health — San Diego, California, United States
  • Kaiser Permanente — San Francisco, California, United States
  • Stanford University — Stanford, California, United States
  • University of Colorado — Aurora, Colorado, United States
  • South Denver Cardiology Associates, P.C. — Littleton, Colorado, United States
  • St. Elizabeth's Medical Center — Washington D.C., District of Columbia, United States
  • Medical Faculty Associates George Washington University — Washington D.C., District of Columbia, United States
  • BayCare Health Systems — Clearwater, Florida, United States
  • University of Florida — Gainesville, Florida, United States
  • Mayo Clinic — Jacksonville, Florida, United States
  • University of Miami - Leonard S. Miller SOM — Miami, Florida, United States
  • Sarasota Memorial Health Care System — Sarasota, Florida, United States
  • Cleveland Clinic Florida — Stuart, Florida, United States
  • Baycare Health Systems Clearwater — Winter Haven, Florida, United States
  • Emory University — Atlanta, Georgia, United States
  • Georgia Arrhythmia Consultants and Research Institute — Warner Robins, Georgia, United States
  • University of Illinois Chicago — Chicago, Illinois, United States
  • Northwestern University — Chicago, Illinois, United States
  • Rush University Medical Center — Chicago, Illinois, United States
  • University of Chicago — Chicago, Illinois, United States
  • Loyola University Chicago — Chicago, Illinois, United States
  • Alexian Brothers Health System — Elk Grove Village, Illinois, United States
  • NorthShore University HealthSystem — Evanston, Illinois, United States
  • Midwest Cardiovascular Institute — Naperville, Illinois, United States
  • Ascension St. Vincent — Indianapolis, Indiana, United States
  • University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
  • Maine Medical Partners MaineHealth Cardiology — Scarborough, Maine, United States
  • Johns Hopkins Univeristy — Baltimore, Maryland, United States
  • Tufts Medical Center — Boston, Massachusetts, United States
  • Mass General Hospital — Boston, Massachusetts, United States
  • Brigham and Women's Hospital — Boston, Massachusetts, United States
  • Boston Medical Center — Boston, Massachusetts, United States
  • BMC - Brighton — Boston, Massachusetts, United States
  • Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
  • Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
  • UMass Chan Medical School — Worcester, Massachusetts, United States
  • Henry Ford Health — Detroit, Michigan, United States
  • Corewell Health (Former Spectrum Health) — Grand Rapids, Michigan, United States
  • Trinity Health Grand Rapids/Mercy Health — Grand Rapids, Michigan, United States
  • William Beaumont Hospital — Royal Oak, Michigan, United States
  • Trinity Health Michigan Heart - Ann Arbor — Ypsilanti, Michigan, United States
  • Essentia Health The Duluth Clinic — Duluth, Minnesota, United States
  • Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
  • Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States
  • University of Minnesota — Minneapolis, Minnesota, United States
  • University Health Truman Medical Center — Kansas City, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Advanced Heart and Vascular Institute of Hunterdon — Flemington, New Jersey, United States
  • Hackensack Meridian Health — Hackensack, New Jersey, United States
  • Rutgers, the State University of New Jersey — Piscataway, New Jersey, United States
  • The Valley Hospital, Inc. — Ridgewood, New Jersey, United States
  • University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States
  • Presbyterian Healthcare Services — Albuquerque, New Mexico, United States
  • University at Buffalo — Buffalo, New York, United States
  • NYU Langone Health — New York, New York, United States
  • Columbia University Medical Center — New York, New York, United States
  • Weill Medical College of Cornell University — New York, New York, United States
  • NewYork Presbyterian - Queens — Queens, New York, United States
  • Staten Island University Hospital-Northwell Health — Staten Island, New York, United States
  • Stony Brook University — Stony Brook, New York, United States
  • Westchester Medical Center — Valhalla, New York, United States
  • White Plains Hospital — White Plains, New York, United States
  • University of North Carolina — Chapel Hill, North Carolina, United States
  • Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
  • The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
  • University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
  • Ohio State University Medical Center — Columbus, Ohio, United States
  • OhioHealth Research Institute — Columbus, Ohio, United States
  • Wooster Community Hospital — Wooster, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Cardiology Consultants of Philadelphia — Paoli, Pennsylvania, United States
  • Thomas Jefferson University — Philadelphia, Pennsylvania, United States
  • Allegheny Singer Research Institute — Pittsburgh, Pennsylvania, United States
  • Penn State Health Medical Group Berks Cardiology — Wyomissing, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • MUSC Health Heart and Vascular — Columbia, South Carolina, United States
  • Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
  • University of Texas Southwestern Medical Center — Dallas, Texas, United States
  • Baylor College of Medicine — Houston, Texas, United States
  • Houston Methodist Hospital — Houston, Texas, United States
  • University of Texas Health Science Center at Houston — Houston, Texas, United States
  • University of Utah — Salt Lake City, Utah, United States
  • University of Virginia — Charlottesville, Virginia, United States
  • James River Cardiology — Richmond, Virginia, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • St. Joseph Medical Center Tacoma — Tacoma, Washington, United States
  • University of Wisconsin — Madison, Wisconsin, United States
  • Medical College of Wisconsin Froedtert Hospital — Milwaukee, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record