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Clinical Trials in Israel / NCT05836987
Recruiting Phase 3

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

NCT05836987 · tracked via the Priya Life Science Israel tracker
Phase
Phase 3
Started
2023-07-13
Last updated
2026-09-30

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

AFSW Guided DOACContinuous DOAC therapy

AFSW Guided DOAC: 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: DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
85 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
Banner University Phoenix Arizona Recruiting
University of Southern California - Keck School of Medicine Los Angeles California Recruiting
University of California Los Angeles (UCLA Health) Los Angeles California Recruiting
UC Davis Health Sacramento California Recruiting
Scripps Health San Diego California Recruiting
Kaiser Permanente San Francisco California Not Yet Recruiting
Stanford University Stanford California Recruiting
University of Colorado Aurora Colorado Recruiting
South Denver Cardiology Associates, P.C. Littleton Colorado Recruiting
St. Elizabeth's Medical Center Washington D.C. District of Columbia Recruiting
Medical Faculty Associates George Washington University Washington D.C. District of Columbia Withdrawn
BayCare Health Systems Clearwater Florida Recruiting
University of Florida Gainesville Florida Recruiting
Mayo Clinic Jacksonville Florida Recruiting
University of Miami - Leonard S. Miller SOM Miami Florida Recruiting
Sarasota Memorial Health Care System Sarasota Florida Active Not Recruiting
Cleveland Clinic Florida Stuart Florida Withdrawn
Baycare Health Systems Clearwater Winter Haven Florida Recruiting
Emory University Atlanta Georgia Recruiting
Georgia Arrhythmia Consultants and Research Institute Warner Robins Georgia Recruiting
University of Illinois Chicago Chicago Illinois Recruiting
Northwestern University Chicago Illinois Recruiting
Rush University Medical Center Chicago Illinois Recruiting
University of Chicago Chicago Illinois Recruiting
Loyola University Chicago Chicago Illinois Recruiting
Alexian Brothers Health System Elk Grove Village Illinois Recruiting
NorthShore University HealthSystem Evanston Illinois Recruiting
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Ascension St. Vincent Indianapolis Indiana Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Maine Medical Partners MaineHealth Cardiology Scarborough Maine Recruiting
Johns Hopkins Univeristy Baltimore Maryland Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Mass General Hospital Boston Massachusetts Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Boston Medical Center Boston Massachusetts Recruiting
BMC - Brighton Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Lahey Hospital & Medical Center Burlington Massachusetts Recruiting
UMass Chan Medical School Worcester Massachusetts Active Not Recruiting

+ 53 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05836987 on ClinicalTrials.gov ↗ ← All trials in Israel