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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