Efficacy and Safety of Pulsed Field Ablation in Refractory Bisththis-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Achieve persistent mitral isthmus block
研究概览
简要总结
Efficacy and safety of pulsed field ablation in refractory mitral isthmus-dependent atrial flutter: pulsed field ablation vs. radiofrequency ablation: a preliminary randomized controlled study
详细描述
This study aims to compare the effectiveness of pulse field ablation (PFA) versus radiofrequency ablation (RFCA) in improving mitral valve commissural block rate and atrial tachycardia recurrence rate in patients with refractory mitral valve commissural-dependent atrial flutter.
Study Design:
Randomized Groups: Patients will be randomly assigned to two groups:
Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) 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
- •1.Patients aged ≥18 years. 2.Diagnosed with persistent symptomatic refractory mitral valve commissural-dependent atrial flutter. Refractory mitral valve commissural-dependent atrial tachycardia is defined as:
- •Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
- •Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).
- •3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.
排除标准
- •Pregnant or breastfeeding women.
- •Presence of left atrial thrombus on preoperative imaging.
- •Life expectancy less than 1 year.
- •Coagulation disorders or contraindications to anticoagulant therapy.
结局指标
主要结局
Achieve persistent mitral isthmus block
时间窗: Immediate post-operative mitral isthmus block rate.
After mitral isthmus block, wait for 20 minutes, and obtain persistent MI block after the waiting period.
次要结局
- Episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds occurred.(During the 3-month post-operative follow-up.)
- The safety endpoint(During the 3-month post-operative follow-up.)
研究者
Xu Liu
Professor
Shanghai Chest Hospital