Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Plymouth、英国
- Derriford Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: • 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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Oesophageal Pacing Arm
Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation.
|
Following AF ablation with the aim of isolating the left atrial posterior wall oesophageal pacing and sensing is performed to check for left atrial posterior wall.
entrance and exit block.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Left atrial posterior wall isolation
大体时间：Through study completion, an average of 4 years
|
Measured via invasive left atrial mapping
|
Through study completion, an average of 4 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complication rate
大体时间：Through study completion, an average of 4 years
|
Documentation of the number of complications caused by the oesophageal pacing procedure
|
Through study completion, an average of 4 years
|
|
Feasibility of using device
大体时间：Through study completion, an average of 4 years
|
The success rate of left atrial posterior wall isolation.
|
Through study completion, an average of 4 years
|
合作者和调查者
调查人员
- 首席研究员：Guy Haywood, MD、University Hospital Plymouth NHS Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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