Clinical Research Directory

Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients

This is a multicenter, open-label, superiority randomized controlled trial enrolling adult patients aged 18 to 75 years. All participants have abdominal obesity (BMI ≥ 28 kg/m² with specific waist circumference standards) and non-valvular atrial fibrillation, and have successfully regained normal heart rhythm after their first catheter ablation. The study aims to compare the efficacy and safety of weekly mazdutide injection with conventional routine care in preventing heart rhythm recurrence within 12 months after ablation (excluding a 3-month early recovery blanking period). A total of 24 months will be spent recruiting participants, followed by a 12-month follow-up period. Participants are randomly divided into two groups. The intervention group receives escalating-dose mazdutide subcutaneous injections starting within 48 hours after ablation alongside standard health guidance on diet, exercise and lifestyle. The control group only receives the same routine health guidance without mazdutide treatment. The primary efficacy endpoint is recurrence of atrial arrhythmias (including AF, atrial flutter, and atrial tachycardia) recorded on a standard 12-lead surface ECG for ≥10 seconds, or on a 24-hour Holter monitor (including single-lead ECG patches) for \>30 seconds, at 12 months after a single ablation procedure (after a 3-month blanking period), without the use of any Class I/III antiarrhythmic drugs (AADs).