REDUCE-ICE
Research type
Research Study
Full title
Reducing pacemaker rate using intra-cardiac echocardiography in patients undergoing transcatheter aortic valve implantation
IRAS ID
356260
Contact name
Mohammad Alkhalil
Contact email
Sponsor organisation
Newcastle NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Patients who are scheduled for keyhole procedure to insert a new heart valve (trans-catheter aortic valve implantation or TAVI) may end up with new changes to the electrical system in their heart, including the need for a pacemaker. These electrical changes remain unpredictable. Previous studies have highlighted an area within the heart, referred to as the membranous septum, that hosts part of the electrical system of the heart. The membranous septum varies in length among patients and the relationship between TAVI and the membranous septum play an important role in determining any electrical changes following TAVI procedure. The aim of the study is to record such interaction using a device called intra-cardiac echocardiography (ICE). By recording this relationship, we may be able to find out if there are any future technique to reduce the risk of electrical changes in the heart after TAVI procedure.
Intra-cardiac echocardiography (ICE) is an ultrasound like the one (with gel) you had to diagnose your narrowed heart valve. Instead of obtaining heart images by placing the scan on your chest, ICE is inserted from the top of your leg during your keyhole TAVI procedure. It is then positioned inside your heart and allow physicians to obtain very clear images of your heart including the membranous septum.
The primary endpoint of this study is the incidence of pacemaker rate, among other electrical changes within the heart, at hospital discharge and evaluate their relationship to findings on ICE.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
25/YH/0089
Date of REC Opinion
21 Jul 2025
REC opinion
Further Information Favourable Opinion