Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086861
• Other study ID #: 15/P/094
• Status: Completed
• Phase: N/A
• Start date: March 23, 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: University Hospital Plymouth NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Ablation
• Persistent Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Derriford Hospital	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Plymouth NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left atrial posterior wall isolation	Measured via invasive left atrial mapping	Through study completion, an average of 4 years
Secondary	Complication rate	Documentation of the number of complications caused by the oesophageal pacing procedure	Through study completion, an average of 4 years
Secondary	Feasibility of using device	The success rate of left atrial posterior wall isolation.	Through study completion, an average of 4 years