Qidong Yixin Granules to prevent atrial fibrillation returning after ablation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jyulu@zju.edu.cn
• Phone: 86 13967126090

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FARAFLEX Mapping and Pulsed Field Ablation for Atrial Fibrillation

  This trial tests the FARAFLEX Mapping and PFA System to see if it can safely help adults with drug-refractory paroxysmal or persistent atrial fibrillation.

  Recruiting at 13 sites Boston Scientific Corporation · Jonesboro, Arkansas and 12 other locations · NCT07575269

• Pulsed field ablation for atrial fibrillation in underrepresented minority patients

  This registry will test how well Boston Scientific pulsed field ablation works and how safe it is for Black, Hispanic, Asian, and other underrepresented adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 2 sites Icahn School of Medicine at Mount Sinai · New York, New York and 1 other locations · NCT07535268

• Left Atrial Appendage Occlusion and Rhythm Restoration in AF Patients

  This trial tests a combined procedure using the Volt PFA System and Amulet 2 to see if it safely and feasibly treats atrial fibrillation while also closing the left atrial appendage in adults with AF.

  Recruiting at 13 sites Abbott Medical Devices · Brussels, B CAP R and 15 other locations · NCT07523620

• FARAPULSE pulsed-field waveform treatment for paroxysmal and persistent atrial fibrillation

  This will test new pulsed electrical waveforms delivered by the FARAPULSE PFA system to treat adults with paroxysmal or persistent atrial fibrillation.

  Recruiting at 3 sites Boston Scientific Corporation · Split and 3 other locations · NCT07444320

• PVI Alone vs PVI Plus PWI and SVCI with PFA in Persistent AF

  This study tests whether adding posterior wall isolation and superior vena cava isolation to pulmonary vein isolation with pulsed-field ablation helps people with persistent atrial fibrillation stay in rhythm.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07405359

• Progressive Resistance Training First to Help AF and HFpEF Patients Feel Better

  This trial tests whether starting with progressive resistance training before aerobic exercise can improve exercise capacity and quality of life in people aged 60 and older who have atrial fibrillation and HFpEF.

  Recruiting Northwestern University · Chicago, Illinois · NCT07324772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.