Oesophageal protection during catheter ablation for AF
Research type
Research Study
Full title
Oesophageal protection: a novel approach to improving the safety profile of catheter ablation for atrial fibrillation. A randomised controlled clinical trial
IRAS ID
253844
Contact name
Mark M Gallagher
Contact email
Sponsor organisation
JRES, St George's University of London & St George's University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
When catheter ablation treatment is offered for those with the more advanced form of atrial fibrillation (AF), it is widely recognised that there is a need to conduct more extensive ablation work in and around the cardiac chamber. The posterior wall of the left atrium is close to the oesophagus (food pipe) and so extensive ablation work here carries a risk of oesophageal injury or indeed other structural injury, which may be an extremely serious complication.
This research project focuses on a novel strategy to protect the oesophagus from temperature related injury during catheter ablation of AF. Patients receiving extensive catheter ablation for AF or a planned AF ablation procedure where the risk of oesophageal or structural injury is high will be eligible for inclusion into this clinical trial. They will be fairly allocated (50:50 chance) to having their ablation procedure using a protective oesophageal cooling device or the standard care approach which is an oesophageal temperature probe, to monitor oesophageal temperatures during ablation. After the catheter ablation procedure, the patients will have a follow up endoscopy (a camera test to look at the oesophagus) to review the extent of any oesophageal injury, day(s) post procedure (in a matter of 1-7 days). During their standard clinic follow up, we will also review for any reports of ongoing gastro-oesophageal related symptoms.
The main purpose of this trial is to determine if novel application of this oesophageal protection device can decrease the rate of oesophageal or structural damage related to extensive catheter ablation for AF. This study may also indirectly show that more effective ablation lesions can be delivered as a result of oesophageal protection and improve the success rate of the procedure.REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/2139
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion