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Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

Primary Purpose

Persistent Atrial Fibrillation, Atrial Fibrillation Ablation

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Oesophageal pacing after left atrial posterior wall isolation
Sponsored by
University Hospital Plymouth NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Persistent Atrial Fibrillation focused on measuring Oesophageal Pacing, Hybrid Ablation, Persistent Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Derriford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oesophageal Pacing Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Left atrial posterior wall isolation
Measured via invasive left atrial mapping

Secondary Outcome Measures

Complication rate
Documentation of the number of complications caused by the oesophageal pacing procedure
Feasibility of using device
The success rate of left atrial posterior wall isolation.

Full Information

First Posted
August 29, 2019
Last Updated
October 7, 2021
Sponsor
University Hospital Plymouth NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05086861
Brief Title
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
Official Title
Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Plymouth NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Atrial Fibrillation Ablation
Keywords
Oesophageal Pacing, Hybrid Ablation, Persistent Atrial Fibrillation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oesophageal Pacing Arm
Arm Type
Experimental
Arm Description
Patients undergoing atrial fibrillation ablation to isolate the left atrial posterior wall via catheter or staged hybrid ablation.
Intervention Type
Device
Intervention Name(s)
Oesophageal pacing after left atrial posterior wall isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Left atrial posterior wall isolation
Description
Measured via invasive left atrial mapping
Time Frame
Through study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
Complication rate
Description
Documentation of the number of complications caused by the oesophageal pacing procedure
Time Frame
Through study completion, an average of 4 years
Title
Feasibility of using device
Description
The success rate of left atrial posterior wall isolation.
Time Frame
Through study completion, an average of 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Haywood, MD
Organizational Affiliation
University Hospital Plymouth NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

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