2018-09 SAPIEN 3 Ultra PMCF
Research type
Research Study
Full title
SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
IRAS ID
263855
Contact name
Colum Owens
Contact email
Sponsor organisation
Edwards Lifescience LLC
Duration of Study in the UK
5 years, 6 months, 31 days
Research summary
Aortic stenosis (AS) is one of the most common valvular diseases in developed countries, affecting ~5% of adults above the age of 65, and its prevalence is projected to increase over the next decade with an aging population.
The objective of this post-market clinical follow-up (PMCF) study is to monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific AS. This post CE-marking study will continue to fulfill safety and surveillance reporting requirements under the European Medical Device Directive.
This is a prospective, single-arm, multicenter post-approval study. Up to 50 subjects who undergo the procedure at sites predominantly in the European Union will be assessed at the following intervals: Screening, procedure, post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
This study will use the commercially available Edwards SAPIEN 3 Ultra THV and the SAPIEN 3 THV.
REC name
London - South East Research Ethics Committee
REC reference
19/LO/0771
Date of REC Opinion
15 Jul 2019
REC opinion
Further Information Favourable Opinion