NCT01196923已完成4 期
Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- CardioFocus
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acute Isolation of Pulmonary Veins.
研究概览
简要总结
The purpose of this study is to confirm the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact in the treatment of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, Paroxysmal Atrial Fibrillation (AF)
- •18 to 70 Years of age
排除标准
- •Generally good overall health as determined by multiple criteria
- •Willing to participate in a study
结局指标
主要结局
Acute Isolation of Pulmonary Veins.
时间窗: Acute PVI measured on the day of treatment
99% of pulmonary veins were isolated (72/73)
次要结局
未报告次要终点
研究者
研究点 (1)
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