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

NCT07508618 | Recruiting Phase 4 DMC

• 1 other identifier: SRRSH2025-2022
• Study Type: interventional
• Target: 846
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent Atrial Fibrillation; QiDongYiXin

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of atrial fibrillation

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Qi Dong Yi Xin Granules DRUG

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.

Intervention Group

Placebo DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: collaborator

Study Sites (5)

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

NOT YET RECRUITING

Deqing People'S Hospital

Huzhou, China

NOT YET RECRUITING

Ningbo No.2 Hospital

Ningbo, China

NOT YET RECRUITING

Related Publications (1)

• [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.

  BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lu Yu

CONTACT

86 13967126090; jyulu@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (5)