Efficacy and Safety of Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation: a Multicenter 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 evaluate the efficacy and safety of pulsed field ablation (PFA) in patients with persistent atrial fibrillation (PeAF). We will compare three distinct substrate ablation strategies: anatomical guided ablation (ANAT group), electrogram guided ablation (EGM group), and extensive electro-anatomical guided ablation (EXT group). The study seeks to identify which ablation strategy yields the highest efficacy and safety profiles to potentially guide future clinical practice in the management of PeAF.
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
- •Adults aged 18-80 years diagnosed with persistent atrial fibrillation.
- •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
Anatomical Guided Ablation Group
This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping.
干预措施: Anatomical Guided Ablation (Procedure)
Electrogram Guided Ablation Group
This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths.
干预措施: Electrogram Guided Ablation (Procedure)
Extensive Electro-Anatomical Guided Ablation Group
This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting.
干预措施: Extensive Electro-Anatomical Guided Ablation (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 and Quality of Life Enhancement.(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）)