Study Comparing Continuous Versus Smart Watch-Guided Short-Term Anticoagulation in Adults with Atrial Fibrillation and Low-to-Moderate Stroke Risk

What this Trial Is About

Researchers are evaluating a new approach for managing atrial fibrillation AF in adults aged 22 to 85 who have a history of paroxysmal or persistent AF with low-to-moderate stroke risk. The trial compares the current standard care of continuous use of direct oral anticoagulants DOAC with a time-limited DOAC use guided by an AF-sensing Smart Watch AFSW. This phase 3, multicenter, randomized clinical trial aims to assess if the AFSW-guided DOAC therapy is as effective as continuous therapy in preventing stroke, systemic embolism, or death. Participants are randomly assigned to either the experimental group, where they receive an AFSW linked to their Apple Watch and take DOAC for 30 days following an AF episode detected by the watch, or the control group, who continue their prescribed continuous DOAC regimen without the AFSW guidance. The AFSW passively monitors heart rhythm and alerts both the participant and the study center if a significant AF event occurs. Both groups use the REACT-AF app for study follow-up, but only the experimental group receives the AFSW device with the detection algorithm. During the study, participants will be monitored for up to 60 months with assessments including heart rhythm tracking, clinical evaluations, and safety monitoring. Researchers will measure the occurrence of ischemic stroke, systemic embolism, all-cause mortality, and major bleeding events to compare the two treatment approaches. Participants adherence to DOAC therapy and use of the smart watch device will be tracked, and the study will be conducted across multiple sites including academic and private practices.

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation