Early Closure of Left Atrial Appendage Combined With DOAC Therapy Versus DOAC Therapy Alone for Patients With Atrial Fibrillation and Recent Ischemic Stroke Despite Anticoagulation

What this Trial Is About

Atrial fibrillation AF is a common heart rhythm disorder that can cause strokes due to blood clots. Despite treatment with direct oral anticoagulants DOACs, patients with AF still face a significant risk of stroke. This trial investigates whether adding a procedure called left atrial appendage occlusion LAAO to DOAC therapy is better than DOAC therapy alone in preventing stroke and other cardiovascular problems in people who have had a recent ischemic stroke despite being on anticoagulants. Participants will be randomly assigned to one of two groups one group will receive the LAAO procedure along with DOAC therapy, while the other will continue DOAC therapy alone. The choice of DOAC is determined by the treating doctor. The trial uses a randomized design with blinded assessment of outcomes. Treatment and follow-up will continue for a minimum of 6 months and up to 48 months, with visits every 6 months to monitor health and outcomes. During the study, participants will undergo regular assessments including monitoring for recurrent ischemic stroke, systemic embolism, cardiovascular death, bleeding events, procedure-related complications, and overall health status. Functional neurological outcomes and patient-reported measures will also be evaluated. The study aims to enroll 482 patients and follow them closely to compare the effects of the two treatment strategies over time.

Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy