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NOT YET RECRUITING
NCT07684313

TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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

DEVICE

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