Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07508618

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Persistent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The recurrence rate of atrial fibrillation

    Time frame: From enrollment to the end of treatment at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Lu Yu

CONTACT

[email protected]

86 13967126090

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Collaborators

  • Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: QDYX-AF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.