The INDURE Registry
Research type
Research Study
Full title
Clinical outcomes of patients under the age of sixty undergoing INSPIRIS RESILIA aortic valve replacement: The INDURE Registry (INSPIRIS RESILIA DURABILITY REGISTRY)
IRAS ID
256279
Contact name
Olaf Wendler
Contact email
Sponsor organisation
IPPMed UK LTD
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 1 days
Research summary
The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.
The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0439
Date of REC Opinion
30 Aug 2019
REC opinion
Further Information Favourable Opinion