Optimized Posterior Left Atrial Wall Ablation Strategy for Persistent Atrial Fibrillation: A Multicenter Large-Sample Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 384
- 主要终点
- recurrence of atrial arrhythmias
研究概览
简要总结
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
详细描述
This is an open-label, multicenter, randomized parallel-controlled clinical trial. The study aims to investigate the optimal ablation method for the posterior left atrial wall in patients with persistent atrial fibrillation (PsAF).
The main content of the research includes comparing three approaches through randomization: pulmonary vein isolation (PVI) alone, PVI plus pulse field ablation (PWI), and PVI plus anatomical and potential-guided ablation, to evaluate their effects on reducing the recurrence rate of atrial fibrillation. The study is designed with three groups: the PVI-alone group, the PVI + PWI group, and the PVI plus anatomical and potential-guided ablation group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Paroxysmal AF: Defined as episodes lasting <7 days (or resolved with medication/electrical cardioversion within <7 days).
- •Patients with long-standing persistent AF: Defined as persistent AF lasting >3 years.
- •Patients who have never attempted/pursued cardiac rhythm restoration or sinus rhythm.
- •Contraindication to systemic anticoagulation.
- •Pregnancy.
- •Advanced renal or hepatic failure.
- •Severe valvular heart disease or cyanotic congenital heart disease.
- •Hypertrophic cardiomyopathy.
结局指标
主要结局
recurrence of atrial arrhythmias
时间窗: at least 12 months of follow-up, beyond the initial 3-month blanking period
Following a single ablation procedure, after discontinuation of antiarrhythmic drugs, there should be at least 12 months of follow-up without any documented episodes of atrial arrhythmias (atrial fibrillation \[AF\], atrial tachycardia \[AT\], or atrial flutter \[AFL\]) lasting more than 30 seconds, outside the initial 3-month blanking period.
次要结局
- no occurrence of any documented atrial fibrillation (AF) episode lasting more than 30 seconds(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- occurrence of any documented atrial arrhythmia lasting more than 30 seconds(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- the burden of atrial fibrillation at 12 months of follow-up between different study groups(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- no occurrence of any documented atrial arrhythmia lasting more than 30 seconds(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- no occurrence of any documented persistent atrial arrhythmia lasting more than 7 days(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- no occurrence of any documented symptomatic atrial fibrillation, flutter, or tachyarrhythmia lasting more than 30 seconds(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- Procedure duration / Fluoroscopy time / Radiofrequency ablation time(Record the duration of the surgery, fluoroscopy time, and radiofrequency ablation time immediately after the completion of the radiofrequency ablation procedure, measured in hours.)
- Posterior wall isolation success rate (bidirectional block).(Evaluate from the date of the procedure until the first documented recurrence of atrial arrhythmia, with a maximum assessment duration of 12 months.)
- Number of repeat procedures within at least 12 months of follow-up(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- Number of direct current (DC) cardioversions performed due to atrial fibrillation recurrence within at least 12 months of follow-up.(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- Use of antiarrhythmic drugs at 3 months, at the time of atrial fibrillation recurrence, and at final follow-up.(Evaluate from 3 months post-procedure until the first documented recurrence of atrial fibrillation, with a maximum assessment duration of 12 months)
- Perioperative complications(Perioperative period)
- Quality of life assessments(At least 12 months of follow-up, beyond the initial 3-month blanking period.)
- Psychological distress(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- Functional status(at least 12 months of follow-up, beyond the initial 3-month blanking period)
- Cardiac functional capacity(at least 12 months of follow-up, beyond the initial 3-month blanking period)