Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Left atrial posterior wall isolation
研究概览
简要总结
Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.
Investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study
详细描述
Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.
This would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects capable of giving informed consent,
- •Male or female
- •Aged between 18 and 80 years
- •Undergoing ablation under general anaesthetic with planned isolation of the left atrial posterior wall or who have previously undergone either catheter or surgical ablation for AF with LA posterior wall isolation
排除标准
- •Unable or willing to give fully informed written consent
- •Turned down for general anaesthetic
- •Pregnancy
- •Terminal illness
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.
结局指标
主要结局
Left atrial posterior wall isolation
时间窗: Through study completion, an average of 4 years
Measured via invasive left atrial mapping
次要结局
- Feasibility of using device(Through study completion, an average of 4 years)
- Complication rate(Through study completion, an average of 4 years)