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Not yet recruiting NCT07487532

Acupuncture for Preventing Atrial Arrhythmia Recurrence After Ablation

No phase Interventional Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroacupuncture, Standard Medical Therapy.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Recurrence of Atrial Arrhythmia After Catheter Ablation [Time frame: Up to 12 months after catheter ablation (excluding a 3-month blanking period)]
Secondary outcome measures (6)
  • Change in Left Atrial Diameter [Time frame: Baseline and 12 months after catheter ablation]
  • Change in Left Ventricular End-Diastolic Diameter [Time frame: Baseline and 12 months after catheter ablation]
  • Change in Left Ventricular End-Systolic Diameter [Time frame: Baseline and 12 months after catheter ablation]
  • Change in Left Ventricular Ejection Fraction [Time frame: Baseline and 12 months after catheter ablation]
  • Change in Atrial Fibrillation Burden [Time frame: Baseline and 12 months after catheter ablation]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07487532 · B2026-077

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗