NCT01730807已完成不适用
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Acute Procedural Success
研究概览
简要总结
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.
详细描述
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or older
- •indicated for ablation for Atrial Flutter
排除标准
- •Recent MI/cardiac revascularization
- •Prosthetic Valves
- •recent ablation for atrial flutter
- •atrial flutter with reversible cause
- •Class IV HF
研究组 & 干预措施
IntellaTip XP MiFi
Experimental
Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
干预措施: IntellaTip MiFi XP Catheter (Device)
结局指标
主要结局
Acute Procedural Success
时间窗: one day
The Demonstration of bi-directional isthmus block at the end of the ablation procedure
次要结局
- Complication Rate at procedure(7 days)
研究者
研究点 (1)
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