TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Recruiting
Observational Study
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Tricuspid Valve Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 75 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
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About This Trial
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.
Trial Locations
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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 hypers…
Contacts