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Not yet recruiting NCT07684313

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

— Observational Heart Valve Diseases Heart Diseases Cardiovascular Diseases Tricuspid Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Edwards TRIFORMIS RESILIA heart valve.
Who it may be relevant to
Registry conditions: Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

  • Participant's average mean gradient measurement over time [Time frame: 1 Year]
  • Participant's average peak gradient measurement over time [Time frame: 1 Year]
  • Participant's average Effective Orifice Area (EOA) measurement over time [Time frame: 1 Year]
  • Participant's amount of tricuspid valvular regurgitation measurement over time [Time frame: 1 Year]
  • Participant's right ventricular function over time [Time frame: 1 Year]
  • Participant's amount of paravalvular leak over time [Time frame: 1 Year]
  • Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year [Time frame: Baseline and 1 Year]
Secondary outcome measures (10)
  • Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class [Time frame: Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from all cause mortality [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from cardiovascular mortality [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from valve-related mortality [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from tricuspid valve reintervention [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from valve-related pulmonary embolism [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from valve-related valve thrombosis [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from valve-related hemorrhage [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from valve-related endocarditis [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]
  • Percentage of participant's freedom from tricuspid valve-related heart failure hospitalization [Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Ascension St. Vincent's Hospital — Carmel

Identifiers

NCT: NCT07684313 · 2025-14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗