Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of Pulmonary veins reconnection
研究概览
简要总结
The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.
Currently, two technologies of irrigated ablation catheters are available for PVI.
One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.
The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.
These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.
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
- •Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
- •Age superior or equal to 18 years old, both genders.
- •Patient's oral agreement for study participation after reading information note.
- •Patient affiliated or recipient of a social welfare regimen.
排除标准
- •Age inferior to 18 years old
- •Pregnancy
- •Unbalanced psychiatric disorders
- •Contraindication to atrial fibrillation ablation by endocardial way.
- •Redo-ablation
- •No patient's oral agreement for study participation
结局指标
主要结局
Number of Pulmonary veins reconnection
时间窗: End of ablation procedure
Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)
次要结局
未报告次要终点