“Evidence from large epidemiological studies indicates that stroke risk is influenced not only by the overall burden of atrial fibrillation but also by its pattern, particularly, prolonged episodes or clusters of episodes which we refer to as long episodes of AF, or LEAF. These are either discrete episodes of at least five hours or periods of daily AF burden exceeding five hours both readily identified in an individual with AF using modern digital technologies and AI tools, and probably long enough time in AF to form a clot in the left atrium.” said Peter Milner, M.D., FACC., founder and managing member of XYRA. “In the HARBOR-AF study, we plan to identify patients who experience frequent LEAF using a range of reliable, FDA-approved AF-monitoring technologies, including existing pacemakers and low-cost, convenient wearable devices such as patches and wristbands. Once each patient’s AF burden, risk profile, and symptoms have been established at baseline, we plan to administer budiodarone using a dose-escalation strategy to identify the appropriate dose for that individual over six months. Treatment will be guided by the AF-monitoring systems, with the aim of eliminating LEAF, thereby establishing a safe harbor, while reducing monthly AF burden and associated symptoms. We believe this study could establish a precedent of the first use of cardiac rhythm data collected from smart watches, beyond simply using them for irregular rhythm notifications.”
