Actively Recruiting
Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule
Led by Sir Run Run Shaw Hospital · Updated on 2026-04-02
846
Participants Needed
5
Research Sites
81 weeks
Total Duration
On this page
Sponsors
S
Sir Run Run Shaw Hospital
Lead Sponsor
H
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-80 years (inclusive)
- Diagnosed with non-valvular persistent atrial fibrillation
- Failed at least one antiarrhythmic drug treatment
- Scheduled to undergo initial catheter ablation
- Voluntarily agree to participate and sign informed consent form (or legal guardian/witness if unable)
You will not qualify if you...
- Valvular atrial fibrillation or paroxysmal atrial fibrillation
- New York Heart Association functional class IV or left ventricular ejection fraction below 40%
- Left atrial diameter greater than 55 mm
- Moderate to severe left ventricular hypertrophy (wall thickness over 1.5 cm)
- Recent acute coronary syndrome or need for stent implantation
- Cardiac surgery or catheter ablation within past 6 months
- Atrial fibrillation duration of 5 years or longer
- Hyperthyroidism
- Atrial fibrillation with cardiomyopathy
- Bradyarrhythmia requiring pacemaker implantation
- Known bleeding disorders or severe clotting dysfunction
- Severe liver or kidney impairment
- Allergy to study drug components
- Participation in other interventional clinical trials within past 3 months
- Pregnant or breastfeeding women or life expectancy under 12 months
- Vulnerable groups such as mental illness, cognitive impairment, critical illness
- Other reasons judged unsuitable by investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
3
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Not Yet Recruiting
4
Deqing People'S Hospital
Huzhou, China
Not Yet Recruiting
5
Ningbo No.2 Hospital
Ningbo, China
Not Yet Recruiting
Research Team
L
Lu Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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