Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule

Summary

The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is: Can Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation? Participants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result. If a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. If a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course. Regardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.

Timeline

Start

2026-02-09

Primary completion

2027-08-30

Completion

2027-08-30

Publications

• Background [1] Li H, Song X, Liang Y, et al. Global, regional, and national burden of atrial fibrillation/flutter, 1990-2019: results from the Global Burden of Disease Study 2019. BMC Public Health. 2022;22(1):2015. [2] Gaudino M, Di Franco A, Rong LQ, Piccini J, Mack M. Postoperative atrial fibrillation: from mechanisms to treatment. Eur Heart J. 2023;44(12):1020-1039. [3] Cosedis Nielsen J, et al. POWDER-AF trial: Effect of continued antiarrhythmic therapy after ablation. N Engl J Med. 2016. [4] Huang H, Liu Y, Shuai W, et al. Atrial tachyarrhythmia prevention by Shensong Yangxin after catheter ablation for persistent atrial fibrillation: the SS-AFRF trial. Eur Heart J. 2024;45(40):4305-4314. [5] 郁一波,陶春兰,方任远,等.稳心颗粒结合氯沙坦钾对房颤射频消融术后心室重构的预防效果及对复发率的影响[J].中华中医药学刊,2023,41(06):191-194. [6] 谭巨浪,胡晓军.中医药治疗心房颤动的临床研究进展[J].中西医结合心血管病电子杂志,2020,8(13):163-164. [7] 高原,吴莹,李彬,等.芪冬颐心颗粒通过抑制Nav1.5和Kv4.3电流改善心肌缺血再灌注心律失常的电生理机制[J].中华中医药杂志,2025,40(04):1883-1891.

Drugs

Indications