TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
← catalyst calendarNCT07684313 · readout ≤ 1,473 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
—
Status
Not yet recruiting
Study type
Observational
Enrollment
75estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | Aug 2026 | estimated | When the study began enrolling |
| Primary completion | Aug 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2034 | estimated | The whole study's end, after follow-up |
| First posted | 2026-07-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Heart Valve Diseases
- Heart Diseases
- Cardiovascular Diseases
- Tricuspid Valve Disease
Intervention
- Device: Edwards TRIFORMIS RESILIA heart valve
Primary outcomes
what the primary-completion date above is the date OFParticipant's average mean gradient measurement over time
measured 1 Year
Participant's average peak gradient measurement over time
measured 1 Year
Participant's average Effective Orifice Area (EOA) measurement over time
measured 1 Year
Participant's amount of tricuspid valvular regurgitation measurement over time
measured 1 Year
Participant's right ventricular function over time
measured 1 Year
Participant's amount of paravalvular leak over time
measured 1 Year
Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year
measured Baseline and 1 Year
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