clinical trial · NCT06569602
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Edwards Lifesciences·—·recruiting·n = 500
Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular DiseasesTranscatheter Tricuspid Valve Replacement
brief summary
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
started
Oct 1, 2024
primary completion
Sep 30, 2030
completion
Sep 30, 2033
last updated
Oct 31, 2024
detailed description
This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.
Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.
official title
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol