RecruitingAtrial Fibrillation

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Eligible age

22–85 yrs

Accepts

All genders

Locations

29 states

Healthy volunteers

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About this 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.

Sponsor: Johns Hopkins University

You may qualify if…

✓ 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 1-4 for men and 2-4 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

You may not qualify if…

✕ 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 aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.
✕ 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 standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.
✕ 8. Ablation for AF within the last 2 months.