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

Recruitingn/aAges 18 Years - anyAllEdwards Lifesciences
NCT07684313 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Edwards TRIFORMIS RESILIA heart valve
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Where

1 site
Ascension St. Vincent's Hospital
Carmel, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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