Comparative Study of Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 107
- 试验地点
- 6
- 主要终点
- Total Fluoroscopy Time
研究概览
简要总结
The purpose of this study is to determine the change in median radiation exposure time and median procedure time following guided radiofrequency (RF) ablation among subjects undergoing treatment for paroxysmal atrial fibrillation with either the CARTO® 3 or the NavX(TM) System.
It is hypothesized that described features will reduce the median radiation exposure during the CARTO® 3 system-guided procedures compared to the NavX(TM) system-guided procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •All patients referred for a first radiofrequency ablation procedure for treatment of paroxysmal atrial fibrillation (AF episodes that last less than 30 days and are not terminated via cardioversion) and who are considered eligible for treatment by the physician.
排除标准
- •There are no study specific exclusion criteria for this observational study. The exclusion criteria will be conditions that, in the physicians opinion, preclude an RF ablation procedure because the procedure risks outweigh any potential benefits for the subject.
结局指标
主要结局
Total Fluoroscopy Time
时间窗: Throughout the Total Duration of the Procedure
The primary outcome measure of this study is to measure and compare total fluoroscopy exposure time (minutes) at the conclusion of radiofrequency ablation for the treatment of paroxysmal atrial fibrillation, when guided by the CARTO® 3 or the NavX(TM) System in similar procedures.
次要结局
- Total Procedure Time(Total Duration of the Procedure)