Edwards Sapien 3 Ultra delivery system used with S3 and S3 Ultra THV.
Research type
Research Study
Full title
A Prospective, Single-arm, Multi-centre Study of the SAPIEN 3 Ultra Delivery System used with the SAPIEN 3 Ultra THV and SAPIEN 3 THV in Intermediate Risk Patients with Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
IRAS ID
244949
Contact name
Stepanka Strnadova
Contact email
Sponsor organisation
Edwards Lifesciences LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 3 months, 31 days
Research summary
Aortic Stenosis is one of the commonest forms of valvular disease in developed countries, and left un-treated leads to debilitation and can be life threating. Aortic valve replacement is the gold standard treatment for this disease in subjects who do not have a high procedural risk and outcomes after surgical AVR (SAVR) are excellent in those patients. Transcatheter aortic valve replacement (TAVR) was developed for subjects deemed to be at high risk during surgery and numerous studies have compared TAVR to SAVR and in this high risk category, TAVR has been found to be superior to SAVR.
This study will evaluate the procedural safety and performance of the SAPIEN 3 Ultra Delivery System and Axela Sheath with the SAPIEN 3 Ultra Transcatheter Heart Valve (THV) (20, 23 and 26 mm sizes) and SAPIEN 3 THV System (29 mm size). The SAPIEN 3 Ultra THV design differs from the SAPIEN 3 design only with respect to the weave of the outer skirt and attachment of the skirt to the frame. The SAPIEN 3 Ultra Delivery System allows the THV to be crimped directly onto the deployment balloon eliminating the need for valve alignment and reducing the number of procedural steps. The Axela Sheath has a reduced profile of 14 French across all valve sizes.
The study will be conducted at 4 sites across Canada and the UK and involve 20 subjects having the implant. Each subjects will be followed up after 30 days, 6 months and yearly to 5 years to determine the safety and performance of the device. These being measured in terms of mortality, the need for surgery and valve regurgitation, as well as other vascular problems.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0558
Date of REC Opinion
24 Apr 2018
REC opinion
Favourable Opinion