Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

NCT05086861 | Completed

• 1 other identifier: 15/P/094
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Atrial Fibrillation; Atrial Fibrillation Ablation

Keywords

Oesophageal Pacing; Hybrid Ablation; Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Left atrial posterior wall isolation

  Measured via invasive left atrial mapping

  Through study completion, an average of 4 years

Secondary Outcomes (2)

• Complication rate

  Through study completion, an average of 4 years

• Feasibility of using device

  Through study completion, an average of 4 years

Study Arms (1)

Oesophageal Pacing Arm

EXPERIMENTAL

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

Interventions

Oesophageal pacing after left atrial posterior wall isolation 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.

Oesophageal Pacing Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Derriford Hospital

Plymouth, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Haywood, MD

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: October 21, 2021
• Study Start: March 23, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: October 21, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)