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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

RecruitingPhase 3

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

Who can join

Ages 22 to 85 · All sexes

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)

About the study

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.

What is being tested

Sponsor: Johns Hopkins University · Participants: 5,350 · Started: Jul 13, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05836987

Locations in the U.S.

ArizonaBanner University, Phoenix
CaliforniaUniversity of California Los Angeles (UCLA Health), Los Angeles
University of Southern California - Keck School of Medicine, Los Angeles
UC Davis Health, Sacramento
Scripps Health, San Diego
Kaiser Permanente, San Francisco (Not yet recruiting)
Stanford University, Stanford
ColoradoUniversity of Colorado, Aurora
South Denver Cardiology Associates, P.C., Littleton
District of ColumbiaSt. Elizabeth's Medical Center, Washington D.C.
FloridaBayCare Health Systems, Clearwater
University of Florida, Gainesville
Mayo Clinic, Jacksonville
University of Miami - Leonard S. Miller SOM, Miami
Baycare Health Systems Clearwater, Winter Haven
GeorgiaEmory University, Atlanta
Georgia Arrhythmia Consultants and Research Institute, Warner Robins
IllinoisLoyola University Chicago, Chicago
Northwestern University, Chicago
Rush University Medical Center, Chicago
University of Chicago, Chicago
University of Illinois Chicago, Chicago
Alexian Brothers Health System, Elk Grove Village
NorthShore University HealthSystem, Evanston
Midwest Cardiovascular Institute, Naperville
IndianaAscension St. Vincent, Indianapolis
IowaUniversity of Iowa Hospitals and Clinics, Iowa City
MaineMaine Medical Partners MaineHealth Cardiology, Scarborough
MarylandJohns Hopkins Univeristy, Baltimore
MassachusettsBMC - Brighton, Boston
Beth Israel Deaconess Medical Center, Boston
Boston Medical Center, Boston
Brigham and Women's Hospital, Boston
Mass General Hospital, Boston
Tufts Medical Center, Boston
Lahey Hospital & Medical Center, Burlington
MichiganHenry Ford Health, Detroit
Corewell Health (Former Spectrum Health), Grand Rapids
Trinity Health Grand Rapids/Mercy Health, Grand Rapids
William Beaumont Hospital, Royal Oak
Trinity Health Michigan Heart - Ann Arbor, Ypsilanti
MinnesotaHennepin Healthcare Research Institute, Minneapolis
Minneapolis Heart Institute Foundation, Minneapolis
University of Minnesota, Minneapolis
MissouriWashington University School of Medicine, St Louis
New JerseyAdvanced Heart and Vascular Institute of Hunterdon, Flemington
Hackensack Meridian Health, Hackensack
Rutgers, the State University of New Jersey, Piscataway
The Valley Hospital, Inc., Ridgewood
New MexicoUniversity of New Mexico Health Sciences Center, Albuquerque
New YorkUniversity at Buffalo, Buffalo
Columbia University Medical Center, New York
NYU Langone Health, New York
Weill Medical College of Cornell University, New York
NewYork Presbyterian - Queens, Queens
Staten Island University Hospital-Northwell Health, Staten Island
Stony Brook University, Stony Brook
Westchester Medical Center, Valhalla
White Plains Hospital, White Plains
North CarolinaUniversity of North Carolina, Chapel Hill
Wake Forest Baptist Health, Winston-Salem
OhioThe Lindner Center for Research and Education at The Christ Hospital, Cincinnati
University of Cincinnati College of Medicine, Cincinnati
Ohio State University Medical Center, Columbus
OhioHealth Research Institute, Columbus
Wooster Community Hospital, Wooster
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
PennsylvaniaCardiology Consultants of Philadelphia, Paoli (Not yet recruiting)
Thomas Jefferson University, Philadelphia
Allegheny Singer Research Institute, Pittsburgh
Penn State Health Medical Group Berks Cardiology, Wyomissing
Rhode IslandRhode Island Hospital, Providence
South CarolinaMedical University of South Carolina, Charleston
MUSC Health Heart and Vascular, Columbia
TexasTexas Cardiac Arrhythmia Research Foundation, Austin
University of Texas Southwestern Medical Center, Dallas
Baylor College of Medicine, Houston
Houston Methodist Hospital, Houston
University of Texas Health Science Center at Houston, Houston
UtahUniversity of Utah, Salt Lake City
VirginiaUniversity of Virginia, Charlottesville
James River Cardiology, Richmond
Virginia Commonwealth University, Richmond
WashingtonSt. Joseph Medical Center Tacoma, Tacoma
WisconsinUniversity of Wisconsin, Madison
Medical College of Wisconsin Froedtert Hospital, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.