Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study

Conditions
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Persistent Atrial Fibrillation, Atrial Fibrillation Ablation

Intervention / Treatment
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* Device: Oesophageal pacing after left atrial posterior wall isolation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oesophageal Pacing Arm<br>Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation. | Device: Oesophageal pacing after left atrial posterior wall isolation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left atrial posterior wall isolation | Measured via invasive left atrial mapping | Through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Documentation of the number of complications caused by the oesophageal pacing procedure | Through study completion, an average of 4 years | 
| Feasibility of using device | The success rate of left atrial posterior wall isolation. | Through study completion, an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oesophageal Pacing, Hybrid Ablation, Persistent Atrial Fibrillation