Atrial Fibrillation (AF)
Conditions
Brief summary
This study aims to evaluate whether acupuncture can reduce the recurrence of atrial arrhythmias after catheter ablation in patients with persistent atrial fibrillation. Catheter ablation is an effective treatment for atrial fibrillation, but recurrence remains common, especially in persistent cases. In this prospective, randomized, open-label trial, 120 patients with persistent atrial fibrillation who have undergone successful catheter ablation will be enrolled and randomly assigned to two groups. The intervention group will receive acupuncture in addition to standard medical therapy, while the control group will receive standard medical therapy alone. Participants will be followed for 12 months. The primary outcome is the recurrence of atrial arrhythmias, including atrial fibrillation, atrial flutter, or atrial tachycardia. Secondary outcomes include cardiac structure and function, atrial fibrillation burden, and quality of life. This study will provide clinical evidence on whether acupuncture can be an effective adjunctive therapy to improve outcomes after catheter ablation.
Interventions
PROCEDUREElectroacupuncture
Electroacupuncture is administered starting on the second day after catheter ablation. Treatment is performed twice weekly for 5 weeks using bilateral Neiguan (PC6) and Jianshi (PC5) acupoints. Low-frequency electrical stimulation (2 Hz) is applied during each session. All procedures are performed by trained practitioners following standardized protocols.
DRUGStandard Medical Therapy
Standard medical therapy is administered after catheter ablation according to current clinical guidelines and physician judgment. This includes antiarrhythmic drugs and anticoagulation therapy as appropriate. Medication use is recorded throughout the study period.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 20 to 75 years * Persistent atrial fibrillation * Undergoing first-time catheter ablation with successful restoration of sinus rhythm * Left atrial diameter \<50 mm * Able to understand the study and provide written informed consent
Exclusion criteria
* Cardiovascular events within the past 3 months (including stroke, transient ischemic attack, myocardial infarction, unstable angina, or cardiac surgery) * Symptomatic hypotension with systolic blood pressure \<100 mmHg on two consecutive measurements * Severe valvular heart disease or other significant structural heart disease * Pregnancy, breastfeeding, or planned pregnancy during the study period * History of pacemaker implantation * Second- or third-degree atrioventricular block * Bifascicular or trifascicular block * Acupuncture treatment for cardiovascular disease within the past 3 months * Severe comorbid conditions, including: 1. Malignant tumors 2. Chronic infectious diseases 3. Severe renal dysfunction (eGFR \<30 mL/min/1.73 m² or requiring dialysis) 4. Moderate to severe liver dysfunction (Child-Pugh class B or C) 5. Anemia (hemoglobin \<90 g/L) 6. Systemic diseases requiring steroid therapy 7. Severe cognitive impairment or dementia 8. Alcohol or substance abuse 9. Life expectancy \<12 months 10. Poor compliance or inability to provide informed consent * Participation in another interventional clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of Atrial Arrhythmia After Catheter Ablation | Up to 12 months after catheter ablation (excluding a 3-month blanking period) | Recurrence of atrial arrhythmia, defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period, detected by 12-lead electrocardiogram or 24-hour Holter monitoring and adjudicated by blinded electrophysiologists. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Atrial Diameter | Baseline and 12 months after catheter ablation | — |
| Change in Left Ventricular End-Diastolic Diameter | Baseline and 12 months after catheter ablation | — |
| Change in Left Ventricular End-Systolic Diameter | Baseline and 12 months after catheter ablation | — |
| Change in Left Ventricular Ejection Fraction | Baseline and 12 months after catheter ablation | — |
| Change in Atrial Fibrillation Burden | Baseline and 12 months after catheter ablation | — |
| Change in Atrial Fibrillation Effect on Quality-of-Life Questionnaire overall score | Baseline, and 1, 3, 6, and 12 months after catheter ablation | AFEQT is a 20-item atrial fibrillation-specific quality-of-life questionnaire. Scores range from 0 to 100, with higher scores indicating better health status / better quality of life. |
Outcome results
None listed