Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation

Effectiveness of Acupuncture for Atrial Tachyarrhythmia Prevention After Catheter Ablation in Persistent Atrial Fibrillation Patients: a Prospective, Open-label, Randomized, Blank-controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Electroacupuncture; Drug: Standard Medical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture Plus Standard Therapy	Procedure: Electroacupuncture; 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.
Active Comparator: Standard Therapy Alone	Drug: Standard 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Combined Modality Therapy; Anesthesia; Analgesia; Acupuncture Therapy; Transcutaneous Electric Nerve Stimulation; Electroacupuncture
• Other Study ID Numbers: B2026-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No