EXPRESSO - European Carto® XP REgistry for Validating Specialized CFAE SOftware
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 13
- 主要终点
- Acute Success
研究概览
简要总结
The purpose of this prospective observational study (registry) is to determine the acute success rate of a complex fractionated atrial electrogram (CFAE) guided ablation procedure using a dedicated software and to determine the functionality and performance of the CFAE software in patients with a type of persistent atrial fibrillation (AF) in routine clinical practice.
详细描述
This was a prospective, multi-center, observational registry study evaluating CARTO® XP CFAE Software (CFAE Software) in subjects with chronic AF requiring CFAE-guided RFCA. Use of the CARTO® 3 System (including CFAE Software) was also allowed. The primary efficacy endpoint was the acute success rate of CFAE-guided radiofrequency catheter ablation (RFCA) using the CFAE Software. Acute success is defined as the subject achieving sinus rhythm at the end of the procedure without electrical or pharmaceutical cardioversion. Secondary endpoints consisted of measures of efficacy (example, performance of the CFAE Software) and of safety (example, number of procedure-related adverse events).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent or longstanding persistent AF
排除标准
- •Previously underwent RF ablation for AF and patients with paroxysmal AF
结局指标
主要结局
Acute Success
时间窗: End of procedure
Sinus rhythm achieved at end of ablation procedure without electrical or pharmaceutical cardioversion
次要结局
- Total Ablation Time(Procedural)
- Total Complex Fractionated Atrial Electrogram (CFAE) Mapping Time(Procedural)
- Total Radiofrequency (RF) Duration(Procedural)
- Total Fluoroscopy Time(Procedural)
- Total Number of Ablated Complex Fractionated Atrial Electrogram (CFAE) Discrete Points(Procedural)