TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
None
Trial design
Treatments tested in this trial
- Edwards TRIFORMIS RESILIA heart valve
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov