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

RecruitingPhase 4Ages 18 Years - 80 YearsAllSir Run Run Shaw Hospital
NCT07508618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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
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What it tests

  • Qi Dong Yi Xin Granules
  • Placebo
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Where

5 sites
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Deqing People'S Hospital
Huzhou, China
Ningbo No.2 Hospital
Ningbo, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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