Study Comparing Catheter Ablation with Left Atrial Appendage Occlusion Versus Catheter Ablation with Oral Anticoagulation in Elderly Frail Patients with Atrial Fibrillation

What this Trial Is About

Atrial fibrillation AF is a common heart rhythm disorder that greatly increases the risk of stroke, heart failure, hospitalization, and death. This research aims to compare two treatment approaches for elderly AF patients who are frail and have a high risk of bleeding. The study evaluates catheter ablation combined with left atrial appendage occlusion LAAO against catheter ablation combined with long-term oral anticoagulation OAC, addressing a current gap in evidence about the best strategy for this vulnerable group. Participants will be randomly assigned to one of two groups one receiving catheter ablation plus LAAO, a device-based procedure to prevent stroke, and the other receiving catheter ablation plus standard oral anticoagulation therapy. The LAAO procedure may be done during the ablation session or separately. After LAAO, participants receive anticoagulation for 90 days, followed by possible de-escalation based on imaging results. The other group continues guideline-directed anticoagulation after ablation. Both groups are closely monitored for safety and effectiveness. During the 24-month study, participants will undergo regular assessments including ECGs, Holter monitoring to track heart rhythm, and imaging tests to evaluate heart function and device status. Researchers will measure outcomes such as stroke, bleeding events, death, AF recurrence, and quality of life. Additional evaluations include frailty scores, cognitive function, and daily living activities. The study also monitors procedural success, hospital stay length, and complications to help determine which treatment better supports elderly patients with AF.

Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation