Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Sinus rhythm in follow-up
研究概览
简要总结
In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
详细描述
This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.
The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.
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
- •age between 18 and 80 years
- •symptomatic persistent (> 7 days lasting) atrial fibrillation
- •at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
- •oral anticoagulation (> 4 weeks prior to ablation)
排除标准
- •moderate to severe valvular heart disease
- •congenital heart disease
- •LV-EF < 35%
- •reversible cause for atrial fibrillation (e.g., hyperthyreosis)
- •prior left atrial ablation or Maze operation
- •left atrial thrombus
结局指标
主要结局
Sinus rhythm in follow-up
时间窗: Sinus rhythm in follow-up
次要结局
未报告次要终点