Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

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

This trial tests whether taking Qidong Yixin Granules after catheter ablation can lower the chance of atrial fibrillation coming back within a year in adults with persistent AF.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 846 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Locations: 5 sites (Hangzhou and 4 other locations)
• Trial ID: NCT07508618 on ClinicalTrials.gov

What this trial studies

This is a Phase 4, randomized study in which adults with non‑valvular persistent atrial fibrillation undergoing first-time radiofrequency catheter ablation are assigned 1:1 to receive either Qidong Yixin Granules or a matching placebo starting within 48 hours after the procedure. Group assignment is computer-randomized and participants receive the assigned oral treatment post-ablation, with follow-up focused on recurrence of AF and monitoring for adverse events. The primary outcome is AF recurrence within one year after ablation, and safety data will be collected throughout the follow-up period. The study is conducted at multiple Zhejiang University–affiliated hospitals in Hangzhou, China.

Who should consider this trial

Good fit: Adults aged 18–80 with non-valvular persistent atrial fibrillation who have failed at least one antiarrhythmic drug and are scheduled for first-time radiofrequency catheter ablation are ideal candidates.

Not a fit: Patients with paroxysmal or valvular AF, severe heart failure (NYHA IV or LVEF <40%), very large left atria (>55 mm), recent cardiac surgery, or other listed exclusions are unlikely to benefit from this study intervention.

Why it matters

Potential benefit: If effective, the granules could reduce AF recurrence after ablation, potentially lowering symptoms and the need for repeat procedures or additional medications.

How similar studies have performed: There is limited high-quality evidence for this specific herbal formula; while some small studies of traditional herbal therapies report possible reductions in AF recurrence, results are mixed and not definitive.

Eligibility criteria

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

Where this trial is running

Hangzhou and 4 other locations

• 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)

Study contacts

• Study coordinator: Lu Yu

Conditions Persistent Atrial Fibrillation; QiDongYiXin