NCT07508618RecruitingPhase 4
Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule
Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 846 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 9 Feb 2026
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07508618
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 846
- From 9 Feb 2026 to the primary completion date, 30 Aug 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation
Other illness
- Patients with acute coronary syndrome or requiring stent implantation
- Known bleeding diathesis, presence of left atrial/left atrial appendage thrombus, or severe hemostasis and coagulation dysfunction
- Patients allergic to the components of the study drug;
- Other vulnerable groups, excluding the elderly/illiterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc
Lab values
- NYHA functional class IV or LVEF \<40%, LA diameter \>55mm;
- Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR \<45 ml/min/1.73 m²;
Age
- Duration of atrial fibrillation ≥5 years;
Other
- Valvular atrial fibrillation or paroxysmal atrial fibrillation
- Moderate to severe left ventricular hypertrophy (wall thickness \>1.5cm);
- Hyperthyroidism;
- Patients with atrial fibrillation and cardiomyopathy;
- Patients with bradyarrhythmia requiring pacemaker implantation
- 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;
- Any other reasons deemed by the investigator as unsuitable for the patient's participation in this study
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Deqing People'S Hospital Coordinator of this site? Confirm its status | Huzhou | China | Not yet recruiting |
| Ningbo No.2 Hospital Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.