Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical Isthmus-Dependent Atrial Flutter
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Acute Efficacy (bidirectional cavotricuspid isthmus block)
研究概览
简要总结
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique regarding the acute and long term efficacy and safety.
详细描述
This randomized study compares two energy sources for the catheter based ablation of typical isthmus-dependent atrial flutter: The (standard) radiofrequency (RF) ablation technique and the cryo-ablation technique. The RF ablation of typical atrial flutter has become a standard approach with very high curing rates and low complication incidence. However, ablation with RF is painful since the underlying cardiac tissue heats up (up to 70-80°C inside the tissue) and especially the target of ablation in typical atrial flutter, the so-called cavo-tricuspid isthmus, is a very pain-receptive area. Cryo-ablation, which destroys tissue by freezing it down to -80 to -90°C, is thought to be less painful or even painless with the same efficacy than RF ablation.
The acute and long term (6 months follow-up, non-invasive) efficacy and safety is the combined endpoint.
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
- •documented atrial flutter which is most probably typical isthmus dependent atrial flutter
- •informed written consent
排除标准
- •prior ablation for atrial flutter
- •concomitant arrhythmia which is treated during the same ablation procedure
- •prior MAZE operation
- •contra indication for catheterization
- •physical or psychiatric disorder making participation in the study impossible
- •pregnancy
- •prior participation in the study
- •participation in another study
研究组 & 干预措施
1
8mm tip ablation catheter for ablation of cavotricuspid isthmus
干预措施: RF ablation of the cavo-tricuspid isthmus (Procedure)
2
irrigated tip ablation catheter for ablation of cavotricuspid isthmus
干预措施: irrigated tip radiofrequency ablation of the cavo-tricuspid isthmus (Procedure)
3
cryo 10mm tip ablation catheter for ablation of cavotricuspid isthmus
干预措施: cryo ablation of the cavo-tricuspid isthmus (Procedure)
4
Cryo 6.5mm tip ablation catheter for ablation of cavotricuspid isthmus
干预措施: cryo 6.5mm tip ablation of the cavotricuspid isthmus (Procedure)
结局指标
主要结局
Acute Efficacy (bidirectional cavotricuspid isthmus block)
时间窗: bidirectional cavotricuspid isthmus block
Long-term efficacy (6 months FU freedom of typical atrial flutter)
时间窗: 6 months
Mortality
时间窗: 6 months
次要结局
- Patients' pain scores during ablation(while hospitalisation)
- Safety of ablational devices(6 months)