MedTrace Logo

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

NCT07684313 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-07-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Edwards TRIFORMIS RESILIA heart valve

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2030-08-31
Completion
2034-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684313 on ClinicalTrials.gov