Effectiveness of Acupuncture for Atrial Tachyarrhythmia Prevention After Catheter Ablation in Persistent Atrial Fibrillation Patients: a Prospective, Open-label, Randomized, Blank-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Recurrence of Atrial Arrhythmia After Catheter Ablation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recurrence of Atrial Arrhythmia After Catheter Ablation
时间窗: 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.
次要结局
- 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 (AFEQT) Score(Baseline, and 1, 3, 6, and 12 months after catheter ablation)