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NCT Number: NCT07487532

Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation

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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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • Severe cognitive impairment or dementia
  • Alcohol or substance abuse
  • Life expectancy <12 months
  • Poor compliance or inability to provide informed consent
  • Participation in another interventional clinical study

Treatment and study plan

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.

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.

Primary outcomes

  1. Recurrence of Atrial Arrhythmia After Catheter Ablation

    Time frame: 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 outcomes

  1. Change in Left Atrial Diameter

    Time frame: Baseline and 12 months after catheter ablation

  2. Change in Left Ventricular End-Diastolic Diameter

    Time frame: Baseline and 12 months after catheter ablation

  3. Change in Left Ventricular End-Systolic Diameter

    Time frame: Baseline and 12 months after catheter ablation

  4. Change in Left Ventricular Ejection Fraction

    Time frame: Baseline and 12 months after catheter ablation

  5. Change in Atrial Fibrillation Burden

    Time frame: Baseline and 12 months after catheter ablation

  6. Change in Atrial Fibrillation Effect on Quality-of-Life Questionnaire overall score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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