clinical trial · NCT07684313
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Edwards Lifesciences·—·not yet recruiting·n = 75
Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesTricuspid Valve DiseaseEdwards TRIFORMIS RESILIA heart valve
brief summary
TRIBLAZE is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in a minimum of 75 participants who will receive the Edwards Lifesciences TRIFORMIS RESILIA surgical tricuspid heart valve, Model 11300T.
started
Aug 1, 2026
primary completion
Aug 1, 2030
completion
Dec 1, 2034
last updated
Jul 6, 2026
detailed description
Subjects in the TRIBLAZE study will be enrolled at up to 15 sites in the United States. The population will be participants requiring replacement of their native or prosthetic tricuspid valve.
official title
Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol