SAPIEN 3 Ultra EU Post-Market Observational Study
Research type
Research Study
Full title
SAPIEN 3 Ultra EU Post-Market Observational Study
IRAS ID
295790
Contact name
Christopher John Malkin
Contact email
Sponsor organisation
Edwards Lifesciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 8 days
Research summary
Summary of Research
Aortic stenosis (AS) is one of the most common valvular diseases in developed countries, affecting ~5% of adults\nabove the age of 65, and its prevalence is projected to increase over the next decade with an aging population.\nThis post-market study will further evaluate real-world outcomes for the SAPIEN 3 Ultra THV System in TAVI centres that are implementing minimalist periprocedural practices and facilitating early discharge home.\nThis is a prospective, observational, single-arm, multicentre post-market study. Up to 500 subjects who will undergo TAVI with the SAPIEN 3 Ultra THV will be enrolled at up to 50 centres predominantly in the European Union.\nClinical data and imaging available from routine clinical assessments performed pre-procedure and through 1-year post-procedure will be collected.Summary of Results
A total of 500 patients were enrolled between 21 April 2021 and 30 May 2023 at 37 sites from Europe. 495 participants were implanted with the SAPIEN 3 Ultra valve, and the average age at enrollment was 74.7 years.The study was designed to evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System in transcatheter aortic valve implantation (TAVI) centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
The available clinical outcomes support the safety of early discharge for patients implanted with the SAPIEN 3 Ultra THV in patients who are deemed low surgical risk and meet clinical and procedural requirements for early discharge as determined by the Heart Team.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0066
Date of REC Opinion
5 Aug 2021
REC opinion
Further Information Favourable Opinion