EZ Steer™ THERMOCOOL® With CF Sensing Capability (THERMOCOOL SMARTTOUCH™) for the Treatment of Atrial Fibrillation and Ventricular Tachycardia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.
研究概览
简要总结
The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.
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
- •Symptomatic atrial fibrillation or ischemic ventricular tachycardia
排除标准
- •Longstanding persistent AF
- •Idiopathic VT
- •Congestive Heart Failure
研究组 & 干预措施
Single-arm Study
This study was completed prior to the implementation of the requirement for specific identification of study arms. As the requirement was not made retroactive to completed studies, we believe this study to be exempt from the stipulation. Also, per PRS definition, since this is for a single-arm/feasibility study, the data elements are optional.
干预措施: Radiofrequency Catheter Ablation (Device)
结局指标
主要结局
The incidence of early onset (within 7 days of ablation procedure performed with the study devivce) primary adverse events.
时间窗: 7 days
The primary safety endpoint is the incidence of early onset primary adverse events.
次要结局
未报告次要终点