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NCT07684313 · ClinicalTrials.gov registry record
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
A clinical trial, sponsored by Edwards Lifesciences.
- Not yet
- Registry status
- 75
- Enrollment target
NCT07684313: Clinical Trial study, sponsored by Edwards Lifesciences.
NCT07684313 is a clinical trial that has not yet begun recruiting, run by Edwards Lifesciences. The registered enrollment target is 75 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07684313 has not yet begun recruiting, sponsored by Edwards Lifesciences.
- NOT YET RECRUITING
- Registry status
- 75 participants
- Enrollment target
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.
Primary Outcome
Mean gradient is the average flow of blood through the tricuspid valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
Interventions
- DEVICE Edwards TRIFORMIS RESILIA heart valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2026-08 |
| Est. Completion | 2034-12 |
What is known before NCT07684313 opens enrollment
NCT07684313 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 75 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Edwards TRIFORMIS RESILIA heart valve is the first listed.
NCT07684313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07684313 about?
NCT07684313 is a clinical study titled "TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE 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 the current status of trial NCT07684313?
This trial is currently not yet recruiting. The enrollment target is 75 participants. The study started on 2026-08. Estimated completion is 2034-12.
What interventions are being tested in trial NCT07684313?
The interventions under investigation include: Edwards TRIFORMIS RESILIA heart valve (DEVICE).
Who is sponsoring clinical trial NCT07684313?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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