EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy using a Novel Device (TRISCEND III)

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.

Principal Investigator

Dr Sam Dawkins

Contact us

Email: oxfordheartresearch@ouh.nhs.uk

IRAS number

346797