Electroporation for Treatment of Persistent and Longstanding Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Durability of isolation
研究概览
简要总结
Comparison of pulmonary vein and left atrial posterior wall isolation durability and clinical outcome between radiofrequency and pulse field ablation in patients with persistent and longstanding persistent atrial fibrillation.
详细描述
Patients with persistent and longstanding persistent atrial fibrillation will be randomized to control and investigational group.
In control group they will receive pulmonary vein and posterior wall ("box lesion") isolation with point by point radiofrequency ablation utilizing the CLOSE protocol with predetermined interlesion distance of up to 6 mm and predetermined ablation index/lesion size index.
In investigational group they will receive pulmonary vein and posterior wall ("box lesion" and additional ablations inside the "box") isolation with point by point pulse field ablation with a predetermined interlesion distance of up to 6 mm and predetermined energy delivery settings.
30 minutes after the last ablation point a high-density mapping of the left atrium will be performed.
Preprocedurally all patients will undergo computer tomography angiography of the left atrium, which will be processed resulting in a three dimensional anatomy reconstruction that will be utilized during the procedures in conjunction with the three dimensional mapping system. Also, left atrial wall thickness will be determined and displayed on the three dimensional anatomy reconstruction.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •atrial fibrillation recorded with 12-lead ECG, holter ECG or implantable device on two occasions at least one week apart
排除标准
- •history of previous catheter ablation, history of previous heart surgery, life expectancy less than one year, any lifethreatening severe acute condition, acute deep venous thrombosis, presence of intracardiac masses or thrombi.
研究组 & 干预措施
Radiofrequency ablation
Pulmonary vein and left atrial posterior wall isolation with point by point radiofrequency ablation.
干预措施: Radiofrequency ablation (Other)
Pulse field ablation
Pulmonary vein and left atrial posterior wall isolation with point by point pulse field ablation.
干预措施: Pulse field ablation (Other)
结局指标
主要结局
Durability of isolation
时间窗: 3 months
Testing for durability of pulmonary vein and left atrial posterior wall isolation in both study arms with high density endocardial remapping. Absence of electrical activity or voltage inside ablation lines of less than 0.05 mV or presence of exit block upon pacing with local capture will be considered as proof of pulmonary vein and posterior left atrial wall isolation.
次要结局
- Freedom from atrial arrhythmias(12 months)
- Intracardiac electrograms analysis(1 day)
- Recording of complications(30 days)
研究者
Matevz Jan
MD
University Medical Centre Ljubljana