Pulmonary Vein Isolation Using High Power - Short Duration Versus Ablation Index: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Single procedure success rate, identified by 48-hours Holder-ECGs every three months
研究概览
简要总结
The single procedure success rates of durable pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF) varies between 80 and 90 %.
This prospective, randomized study investigated the efficacy of pulmonary vein isolation with RF-energy following the CLOSE protocol with standard energy application (30 Watts) versus PVI with RF-energy with high power settings (45 Watts).
详细描述
A total number of 176 patients undergoing de-novo catheter ablation for paroxysmal AF are planned to be randomized to two different treatment arms. In group-A patients, PVI was performed with RF-energy with standard power settings of 30 Watts in a temperature-controlled mode.
The ablation procedure in group B was performed with RF-energy with higher power settings of 45 Watts. In both groups the ablation is performed with ablation index (AI) and following the CLOSE protocol (AI and ≤ 6 mm interlesion distance using a surround flow catheter, Biosense Webster Thermocool STSF).
A total of 88 patients are planned to be randomized into each group, the follow-up period will be 12 months after the first procedure.
The primary endpoint is freedom of all atrial arrhythmias after one procedure. The secondary endpoint is procedural time. The third endpoint is safety.
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
- Single (Investigator)
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
- 是
入选标准
- •Paroxysmal atrial fibrillation
- •written informed consent
排除标准
- •inability to obtain written informed consent
- •persistent atrial fibrillation
结局指标
主要结局
Single procedure success rate, identified by 48-hours Holder-ECGs every three months
时间窗: 1 year
Freedom of any atrial arrhythmia of more than 30 sec during a follow-up period of 12 months after the first procedure.
次要结局
- Procedural data(1 year)
研究者
Peter Ong, MD
Consultant Cardiologist (in German: Oberarzt)
Robert Bosch Medical Center