Study Comparing Stopping vs Continuing Anticoagulant Medication After Atrial Fibrillation Ablation Using Intensive Heart Rhythm Monitoring

What this Trial Is About

Researchers are evaluating whether stopping oral anticoagulant medication after a successful atrial fibrillation ablation can lower bleeding risks without increasing the chances of death or blood clots. This randomized, open-label trial involves adults aged 18 to 80 years who are between 60 and 365 days post-ablation, have a specific risk score of 2 or higher, no prior stroke or embolism, continuous use of certain anticoagulants, and no signs of recurring atrial arrhythmia. Participants are randomly assigned to either stop their anticoagulant medication immediately or continue taking it according to guidelines. All participants undergo close heart rhythm monitoring using a smartwatch capable of single-lead ECG and scheduled Holter or ECG patch monitoring at least every six months, with encouraged monitoring every two months. If any recurrence of atrial arrhythmia is detected, participants exit the trial. Study visits occur at months 3 and 6 after randomization, then every six months, with additional follow-ups every two months. Throughout the study, researchers collect data on serious outcomes including death, stroke, systemic embolism, and bleeding events for up to 48 months. They also assess quality of life, anxiety, depression, and atrial fibrillation recurrence through questionnaires. The study includes a planned 4,100 participants and is sponsored by Beijing Anzhen Hospital, aiming to provide detailed safety and effectiveness information on anticoagulation management after atrial fibrillation ablation.

Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation