Oesophageal Protection during AF Ablation: a multi-centre study
Research type
Research Study
Full title
Improving Oesophageal Protection during AF ablation: A Multi-centre Study.
IRAS ID
290265
Contact name
Mark M Gallagher
Contact email
Sponsor organisation
Advanced Cooling Therapy LLC. dba Attune Medical
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2020-004759-33, EudraCT number
Duration of Study in the UK
4 years, 2 months, 28 days
Research summary
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF.
It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result.
In a recent study, we have shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before we can say that this type of probe is better in protecting the oesophagus.
The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.REC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/1306
Date of REC Opinion
21 Dec 2020
REC opinion
Favourable Opinion