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)

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.

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 18 years or older * Indication for TRIFORMIS valve implant for native or prosthetic valve dysfunction * Provide written informed consent prior to the 30-day imaging follow-up * Willing and able to return for scheduled follow-up visits Exclusion Criteria: • Untreatable hypersensitivity to nitinol alloys (nickel and titanium)

Interventions

Device
Edwards TRIFORMIS RESILIA heart valve
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Location

Ascension St. Vincent's Hospital
Carmel, Indiana