← Back to all trials
Not Yet Recruiting
NCT07684313
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Conditions: Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases, Tricuspid Valve Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 75
Sponsor: Edwards Lifesciences
Location: Ascension St. Vincent's Hospital Carmel Indiana
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.
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)
Source: ClinicalTrials.gov (NCT07684313). StuddyBuddy aggregates publicly available trial information.
