FIRE AND ICE Re-Ablations: Retrospective Data Collection on Re-ablations Performed Within the FIRE AND ICE Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 13
- 主要终点
- Re-ablation Procedure Times as Measured in the Cath Lab
研究概览
简要总结
Retrospective data collection on re-ablations performed within the FIRE AND ICE Trial.
详细描述
The purpose of this retrospective data collection on re-ablations performed in both treatment arms (Cryo arm and Radiofrequency arm) of the FIRE AND ICE Trial is to gain insight into re-occurrence of atrial arrhythmias resulting in a re-ablation after a performed index ablation procedure. Data to be collected from subject charts include pulmonary vein anatomy, documented atrial arrhythmias prior to re-ablation, pulmonary vein reconnection, pulmonary vein ablation lesion gaps and gap location, ablation lesions performed during the re-ablation, procedure parameters of the RF or cryo catheter utilized during the re-ablation, and success of re-ablations performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Re-ablation Procedure Times as Measured in the Cath Lab
时间窗: At time of re-ablation
Re-ablation procedure times as measured in the cath lab
Number of Participatns With Adenosine Testing
时间窗: At time of re-ablation
Number of participants with adenosine testing
Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure
时间窗: At time of re-ablation
Number of reconnected pulmonary veins as documented in cath lab / imaging
Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant
时间窗: At time of re-ablation
Number of gaps and location of gaps present in pulmonary vein ablation lesions as seen in the cath lab / imaging
Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure
时间窗: At time of re-ablation
Description of all ablation lesion sets created during re-ablation procedure
Percentage of Participants With Acute Procedural Success of Re-ablation Procedure
时间窗: At time of re-ablation
Summarize acute procedural success of re-ablation procedure per treatment arm
Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge
时间窗: From Date of Hospital admission until the date of hospital discharge up to 36 month FU period
Number of hospital days for re-ablation procedure form admission to discharge
Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation
时间窗: At time of re-ablation
Number of documented atrial arrhythmias as assessed by ECG prior to the re-ablation
Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure
时间窗: Date of hospital discharge, assessed during the 36 month FU period
Anti-arrhythmic drug use at time of discharge from the re-ablation procedure via medical log on AADs
次要结局
未报告次要终点