Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation

NCT07487532 | Not Yet Recruiting

• 1 other identifier: B2026-077
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Acupuncture Plus Standard Therapy

EXPERIMENTAL

Procedure: Electroacupuncture

Standard Therapy Alone

ACTIVE COMPARATOR

Drug: Standard Medical Therapy

Interventions

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.

Acupuncture Plus Standard Therapy

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.

Standard Therapy Alone

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Malignant tumors
• Chronic infectious diseases
• Severe renal dysfunction (eGFR \<30 mL/min/1.73 m² or requiring dialysis)
• Moderate to severe liver dysfunction (Child-Pugh class B or C)
• Anemia (hemoglobin \<90 g/L)
• Systemic diseases requiring steroid therapy

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share