TRISCEND III EU study
Research type
Research Study
Full title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy using a Novel Device
IRAS ID
346797
Contact name
Sam Dawkins
Contact email
Sponsor organisation
Edwards Lifesciences
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
7 years, 0 months, 31 days
Research summary
This is a multi-center, multinational study of a CE marked Device called the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement used within a routine standard of care setting.
This main purpose of the study will be to collect additional data on routine treatment with the Edwards EVOQUE System to expand the available data on the safety and performance of this valve replacement system. The EVOQUE tricuspid valve replacement system is intended for the reduction of tricuspid regurgitation (TR) for patients who remain symptomatic on medical therapy and in whom no other surgical or transcatheter treatment option exists per heart team decision. The EVOQUE system percutaneously delivers the Implant to the tricuspid valve via femoral vein access using a transvenous approach.
During this study, data about the participants' health and the results of their medical treatment with the Edwards EVOQUE System will be collected and recorded, namely from the time of consent until their discharge from hospital, then after 30 days, and then once a year for 5 years after device implantation.
The trial will be conducted in up to 45 sites in Europe and a maximum of 500 participants will be enrolled. Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.
REC name
London - Stanmore Research Ethics Committee
REC reference
25/PR/1360
Date of REC Opinion
4 Dec 2025
REC opinion
Further Information Favourable Opinion