TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) (NCT07684313) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
United States75 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Participant's average mean gradient measurement over time
Timeframe: 1 Year
2
Participant's average peak gradient measurement over time
Timeframe: 1 Year
3
Participant's average Effective Orifice Area (EOA) measurement over time
Timeframe: 1 Year
4
Participant's amount of tricuspid valvular regurgitation measurement over time
Timeframe: 1 Year
5
Participant's right ventricular function over time
Timeframe: 1 Year
6
Participant's amount of paravalvular leak over time
Timeframe: 1 Year
7
Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year