Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule (QDYX-AF)

Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms

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.

Study Overview

• Status: Recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Drug: Qi Dong Yi Xin Granules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 846
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lu Yu; Phone Number: 86 13967126090; Email: jyulu@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Not yet recruiting
    • the Second Affiliated Hospital Zhejiang University School of Medicine
    • Principal Investigator: Dongchen Zhou
    • Contact: ZheJun Cai; Phone Number: 0571-87783777
  • Hangzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: DongChen Zhou; Phone Number: (0571)87236114
    • Principal Investigator: Dongchen Zhou
  • Hangzhou, China
    • Recruiting
    • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
    • Contact: Lu Yu; Phone Number: 8613967126090; Email: jyulu@zju.edu.cn
    • Principal Investigator: Lu Yu
  • Huzhou, China
    • Not yet recruiting
    • Deqing People'S Hospital
    • Contact: FangFang Huang; Phone Number: 0572-8818120
    • Principal Investigator: FangFang Huang
  • Ningbo, China
    • Not yet recruiting
    • Ningbo No.2 Hospital
    • Principal Investigator: XianFeng Du
    • Contact: Xianfeng Du; Phone Number: 0574-83870999

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years (inclusive);
• Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo initial ablation;
• Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read or sign the informed consent form due to reasons such as lack of capacity, the informed consent process must be completed and signed by their legal guardian. If the subject is unable to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed and signed by a witness.

Exclusion Criteria:

• Valvular atrial fibrillation or paroxysmal atrial fibrillation
• NYHA functional class IV or LVEF <40%, LA diameter >55mm;
• Moderate to severe left ventricular hypertrophy (wall thickness >1.5cm);
• Patients with acute coronary syndrome or requiring stent implantation
• Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation
• Duration of atrial fibrillation ≥5 years;
• Hyperthyroidism;
• Patients with atrial fibrillation and cardiomyopathy;
• Patients with bradyarrhythmia requiring pacemaker implantation
• Known bleeding diathesis, presence of left atrial/left atrial appendage thrombus, or severe hemostasis and coagulation dysfunction
• Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR <45 ml/min/1.73 m²;
• Patients allergic to the components of the study drug;
• Patients who are currently participating or have participated in other interventional clinical studies within the past 3 months.
• Pregnant or lactating women, or those with an expected lifespan of <12 months;
• Other vulnerable groups, excluding the elderly/illiterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc
• Any other reasons deemed by the investigator as unsuitable for the patient's participation in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	Drug: Qi Dong Yi Xin Granules; 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.
Placebo Comparator: Control Group; 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.	Drug: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The recurrence rate of atrial fibrillation	From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital
• Collaborators: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• [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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; QiDongYiXin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: SRRSH2025-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No