INSIDE PVs study
Research type
Research Study
Full title
INtra-procedural ultraSound Imaging for DEtermination of atrial wall thickness and acute tissue changes during isolation of the Pulmonary Veins
IRAS ID
156673
Contact name
Timothy Betts
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Ablation is a treatment used to control or correct certain types of abnormally fast heart rhythm as atrial fibrillation (AF).
For AF, the aim of ablation is to isolate the pulmonary veins from the left atrium (LA, one of the chambers of the heart) at the point where they join. This can be done by using different energies, (radiofrequency, cryo or laser energy) and when successful, it can prevent AF.
Unfortunately, regardless of the technology used, the long term success rate of this approach is still not as good as hoped for and there is an associated risk of heart perforation and collateral damage which although small, is not negligible.
Two main difficulties of this procedure are:
1. During the operation it is necessary to produce a full-thickness scar in order to isolate the pulmonary veins permanently. However the heart wall in the left atrium (LA) has a variable thickness, even in different areas of the same patient.
2. Very little is known about the acute tissue changes produced by the different energies used during AF ablation.
Real-time information about LA wall thickness and acute changes during energy delivery for ablation would be extremely useful to:
a) predict the achievement of permanent lesions,
b) identify the possible causes of ablation failure
c) avoid the occurrence of perforation and/or other collateral damage.
In order to improve this knowledge, we plan to carry out a study in patients undergoing AF ablation. It will look at practical and safe ways to measure the LA wall thickness of the patient and its acute tissue changes occurring during PV isolation.
In addition to standard care, patients will undergo intravascular ultrasound imaging during the AF ablation procedure to measure the LA wall thickness before and soon after energy delivery. The obtained measurements will be compared with corresponding measurements from the standard-care pre-procedural cardiac Computed Tomography (CT) scan and an additional "research" cardiac CT performed after the AF ablation.
Despite not being currently used for LA wall thickness imaging, intravascular ultrasound is routinely used for cardiac procedures, so we are not concerned about the safety implications of their use.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0379
Date of REC Opinion
31 Aug 2016
REC opinion
Favourable Opinion