NCT03988244已完成不适用
Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CardioFocus
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Ablation time
研究概览
简要总结
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the original HeartLight catheter in the treatment of persistent atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •early persistent AF, failure of at least one AAD, others
排除标准
- •overall good health as established by multiple criteria
结局指标
主要结局
Ablation time
时间窗: Acute - at the end of the index procedure
Ablation time
次要结局
- PV Isolation(Acute - at the end of the index procedure)
- PAE Rate(30 Days)
- AF Free Rate(6 and 12 months)
- Procedure time(Acute - at the end of the index procedure)
研究者
研究点 (1)
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