TRIBLAZE Study: Edwards TRIFORMIS RESILIA Heart Valve for Tricuspid Valve Disease
This observational study, called TRIBLAZE, is looking at the safety and performance of the Edwards TRIFORMIS RESILIA heart valve. This valve is used to surgically replace a diseased tricuspid valve (one of the four valves in your heart). The study aims to understand how well the valve works in real-world settings. You might be able to join if you are 18 or older and need a TRIFORMIS valve implant for your tricuspid valve. The study will measure how well the valve is working, specifically looking at measurements like average mean gradient, peak gradient, and effective orifice area, all measured at 1 year. The current recruitment status is unclear.
- Study design
- This is an observational, single-arm study involving at least 75 participants across up to 15 sites in the United States.
- What's involved
- You would need to provide written informed consent before a 30-day imaging follow-up and be able to attend scheduled follow-up visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary measurements for the study are taken at 1 year after the valve implant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Participant's average mean gradient measurement over time1 Year
Mean gradient is the average flow of blood through the tricuspid valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
- Participant's average peak gradient measurement over time1 Year
Peak gradient is the maximum value measured of flow of blood through the tricuspid valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
- Participant's average Effective Orifice Area (EOA) measurement over time1 Year
Effective orifice area represents the cross-sectional area of the blood flow downstream of the tricuspid valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
- Participant's amount of tricuspid valvular regurgitation measurement over time1 Year
Valvular regurgitation occurs when the valve in the heart does not close tightly, allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation, 1 = a trace of regurgitation, 2 = mild regurgitation, 3 = moderate regurgitation, and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
- Participant's right ventricular function over time1 Year
Right ventricular function is the heart's ability to pump deoxygenated blood through the pulmonary circulation into the lungs. Right ventricular function is assessed via echocardiography. It is assessed on a scale of: Normal, Mild dysfunction, Moderate dysfunction, Moderate-severe dysfunction, or Severe dysfunction.
- Participant's amount of paravalvular leak over time1 Year
Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.
- Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 yearBaseline and 1 Year
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a validated, disease-specific health status tool for patients with heart failure. It measures symptoms, physical and social limitations, and quality of life over the previous two weeks. Scores range from 0 to 100, where higher numbers indicate better health and fewer symptoms and lower numbers indicate wore health and more symptoms.