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Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

NCT ID: NCT05086861

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-23

Study Completion Date

2020-10-01

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.

Conditions

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Persistent Atrial Fibrillation Atrial Fibrillation Ablation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Oesophageal Pacing Arm

Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation.

Group Type EXPERIMENTAL

Oesophageal pacing after left atrial posterior wall isolation

Intervention Type DEVICE

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.

Interventions

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Oesophageal pacing after left atrial posterior wall isolation

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guy Haywood, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

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Derriford Hospital

Plymouth, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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15/P/094

Identifier Type: -

Identifier Source: org_study_id