Comparative Efficacy and Safety of Electro-Anatomical Guided Pulsed Field Ablation Versus Radiofrequency Ablation in the Treatment of Persistent Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Freedom from Atrial Arrhythmia Recurrence at 12 Months
研究概览
简要总结
This multicenter, randomized controlled trial aims to compare the efficacy and safety of extensive electro-anatomical guided pulsed field ablation (EXT-PFA) with traditional radiofrequency ablation (RF) in treating persistent atrial fibrillation (PeAF). The trial seeks to determine if EXT-PFA, which integrates anatomical and electrogram-guided strategies, can provide superior outcomes in terms of safety and effectiveness compared to the standard RF ablation approach.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Adults aged 18-80 years diagnosed with persistent atrial fibrillation. 2.Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
排除标准
- •Major valvular diseases needing surgical intervention.
- •Presence of a left atrial thrombus on recent imaging.
- •Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
- •Current Severe Infection.
研究组 & 干预措施
Pulsed field ablation
Utilizing pulsed field ablation (PFA), combining pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates.
干预措施: Pulsed field ablation (Procedure)
Radiofrequency Ablation
Using conventional radiofrequency ablation technology, combines pulmonary vein isolation (PVI) with extensive ablation based on anatomical landmarks (including posterior wall box isolation) and electrogram-guided ablation, aiming to target all potential arrhythmic substrates.
干预措施: Radiofrequency ablation alone (Procedure)
结局指标
主要结局
Freedom from Atrial Arrhythmia Recurrence at 12 Months
时间窗: 12 months after ablation procedure
Proportion of participants free from atrial fibrillation/atrial flutter/atrial tachycardia recurrence at 12 months post-ablation.
次要结局
- Procedural Safety(From enrollment to completion of follow-up（at least 12 months）)
- Symptom Relief (EHRA scores)(From enrollment to completion of follow-up（at least 12 months）)
- Quality of Life (Short Form 36 Health Survey).(From enrollment to completion of follow-up（at least 12 months）)
- Atrial Fibrillation Burden Reduction(From enrollment to completion of follow-up（at least 12 months）)