Computational assessment of bioprosthetic aortic valve function.
Research type
Research Study
Full title
Comparing the in-vivo haemodynamic and biomechanical performance of rapid-deployment Edwards Intuity Elite system and Edwards Magna Ease valve.
IRAS ID
316308
Contact name
Saeed Mirsadraee
Contact email
Sponsor organisation
R&D, Royal Brompton Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Surgical replacement of the aortic valve is the standard treatment for various aortic valve diseases. Bioprosthetic valves are usually made of biological tissue (eg. pig's pericardium) that are mounted to a frame. The valve is designed to function similarly to the patient's own valve. Edwards Magna EASE and Intuity Elite valve have a similar leaflet and mounting designs. However, one is stitched to the left ventricular outflow tract, and the other sticks in by the radial force of the valve's skirt. The latter differences are hypothesized to mechanically affect the aortic root dynamics and blood flow.
In this study, we will use fluid-structure interaction (FSI) models to test the above hypothesis. The modeling technique uses clinical CT and MRI images to produce the mechanical and flow data and therefore is a non-invasive technique. Each consented patient will undergo a CT scan and MRI within 3 months of their valve operation. 20 patients ( 10 from each valve) will be recruited.
The mechanical and flow performance of each valve will be compared. The clinical outcome will be assessed at 3 months & 1 year. Measures of outcome: patient’s satisfaction and evidence of adverse cardiovascular events and mortality.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0522
Date of REC Opinion
27 Aug 2024
REC opinion
Further Information Favourable Opinion