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CompletedNCT05086861Updated Oct 21, 2021

Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

An interventional study of Oesophageal pacing after left atrial posterior wall isolation in Persistent Atrial Fibrillation and Atrial Fibrillation Ablation, sponsored by University Hospital Plymouth NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by University Hospital Plymouth NHS Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Mar 2016, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Persistent Atrial Fibrillation
  • Atrial Fibrillation Ablation

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Keywords

  • Oesophageal Pacing
  • Hybrid Ablation
  • Persistent Atrial Fibrillation
03

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 52 is below the median of 144 across 2,381 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University Hospital Plymouth NHS Trust is the lead sponsor of 53 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • 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

Interventions

  • DeviceOesophageal 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.

06

What researchers measure

Primary outcomes

  1. Left atrial posterior wall isolation

    Measured via invasive left atrial mapping

    Time frame: Through study completion, an average of 4 years

Secondary outcomes

  1. Complication rate

    Documentation of the number of complications caused by the oesophageal pacing procedure

    Time frame: Through study completion, an average of 4 years

  2. Feasibility of using device

    The success rate of left atrial posterior wall isolation.

    Time frame: Through study completion, an average of 4 years

07

Study locations

1 site
  • Derriford Hospital
    Plymouth, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05086861
Lead sponsor
University Hospital Plymouth NHS Trust
Responsible party
Sponsor
First posted
Oct 21, 2021
Start date
Mar 23, 2016
Primary completion
Oct 1, 2019
Completion
Oct 1, 2020
Last update
Oct 21, 2021

Study contacts

Guy Haywood, MD
principal investigator · University Hospital Plymouth NHS Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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