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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Plus Standard Therapy | Experimental |
| |
| Standard Therapy Alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Atrial Arrhythmia After Catheter Ablation | 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. | Up to 12 months after catheter ablation (excluding a 3-month blanking period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
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:
Participation in another interventional clinical study
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2026 | Mar 17, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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|
| Standard Medical Therapy | Drug | 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. |
|
| 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 | 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. | Baseline, and 1, 3, 6, and 12 months after catheter ablation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |