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TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Sponsor: Edwards Lifesciences
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
75
Start Date
2026-08
Completion Date
2034-12
Last Updated
2026-07-06
Healthy Volunteers
No
Interventions
Edwards TRIFORMIS RESILIA heart valve
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve
Locations (1)
Ascension St. Vincent's Hospital
Carmel, Indiana, United States