The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System (The CathVision ECGenius System)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Measurement of AF Cycle Length
研究概览
简要总结
Collect electrophysiological data during atrial fibrillation (AF) ablation procedures to assess the performance of a Signal Complexity Visualization algorithm designed to be integrated into the CathVision ECGenius® System.
详细描述
A prospective, single-center, feasibility study using the CathVision ECGenius® system and a Signal Complexity Visualization Algorithm during radiofrequency (RF) ablation procedures to treat persistent AF.
Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing RF ablation indicated by the investigator for the treatment of persistent atrial fibrillation.
- •Male or non-pregnant female aged ≥ 21 years.
- •Able and willing to provide written informed consent prior to any clinical investigation related procedure.
排除标准
- •Current participation in another investigational drug or device study that interferes with this study.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Life expectancy less than 12 month, in the opinion of the Investigator.
- •Subjects who, in the opinion of the investigator, are not candidates for this study.
- •Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
结局指标
主要结局
Measurement of AF Cycle Length
时间窗: One day - day of procedure
Data collected during the study will be used to test an AF cycle length algorithm
次要结局
未报告次要终点