REACT-AF

Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

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Abnormal heart rhythm, Atrial fibrillation
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All genders
person-wave 22-85
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Overview
Principal Investigator: Christopher Madias, MD

REACT-AF is a multicenter, prospective, randomized clinical trial comparing two treatment strategies for stroke prevention in patients with a history of paroxsymal or persistent atrial fibrillation and moderate stroke-risk.

Study details
Inclusion Criteria
  • 1) Documented history of symptomatic or asymptomatic paroxsymal or persistent atrial fibrillation - the duration of atrial fibrillation must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG
  • 2) CHAD-VASC score of 1-4 without prior stroke or TIA
  • 3) Participant on direct oral anticoagulation at the time of screening
Exclusion Criteria
  • 1) Valvular or permanent atrial fibrillation
  • 2) Current treatment with warfarin and unwilling or unable to take a direct oral anticoagulant
  • 3) Participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (ex. primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling/unable to discontinue use for study duration
Study Requirements

Participants will be screened and consented at an initial visit. At this point, eligible participants will be randomized and the treatment group will be provided instructions using an AF-sensing smartwatch (treatment group). The treatment group will have daily AF monitoring through the smartwatch with a suggested wear time of a minimum of 14 hours per day. Participants in this treatment group will receive an automatic notification alert within an hour when an AF event occurs and participants may be instructed to initiate their previously prescribed DOAC. The control arm will remain on their previously prescribed FDA-approved DOAC regime as indicated by current practice standards.