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

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation Ablation
• Intervention / Treatment: Device: Oesophageal pacing after left atrial posterior wall isolation

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Plymouth, United Kingdom
    • Derriford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oesophageal Pacing Arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Plymouth NHS Trust
• Investigators: Principal Investigator: Guy Haywood, MD, University Hospital Plymouth NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Persistent Atrial Fibrillation; Hybrid Ablation; Oesophageal Pacing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 15/P/094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No