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OpenTrials
Completed

NCT Number: NCT05086861

Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Derriford Hospital

Plymouth, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Left atrial posterior wall isolation

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

    Measured via invasive left atrial mapping

Secondary outcomes

  1. Complication rate

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

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

  2. Feasibility of using device

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

    The success rate of left atrial posterior wall isolation.

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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