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TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
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)
Who can join
Ages 18 and older · All sexes
Full eligibility 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)
About the study
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.
What is being tested
- Edwards TRIFORMIS RESILIA heart valve (device)
Sponsor: Edwards Lifesciences · Participants: 75 · Started: Sep 22, 2026
Contact the study team
- Aya Westbrook, PhD · Phone: 949-250-2500
Official record on ClinicalTrials.gov — NCT07684313
Locations in the U.S.
| Indiana | Ascension St. Vincent's Hospital, Carmel |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.