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
This trial does not accept healthy volunteersQualifiers
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 population
The target population includes adult candidates who require replacement of their native or prosthetic tricuspid valve.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Edwards TRIFORMIS RESILIA heart valve
DeviceSurgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Edwards TRIFORMIS RESILIA heart valve1 intervention
Trial outcomes
Primary outcomes
1
Participant's average mean gradient measurement over time
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.
Time frame
1 Year2
Participant's average peak gradient measurement over time
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.
Time frame
1 Year3
Participant's average Effective Orifice Area (EOA) measurement over time
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.
Time frame
1 Year4
Participant's amount of tricuspid valvular regurgitation measurement over time
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.
Time frame
1 YearSecondary outcomes
1
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
The New York Heart Association functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or anginal syndrome may be present even at rest.
Time frame
Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up2
Percentage of participant's freedom from all cause mortality
Participants' freedom from all cause mortality. Time to events were estimated by Kaplan-Meier method.
Time frame
1-, 2-, 3-, 4-, and 5- Years follow-up3
Percentage of participant's freedom from cardiovascular mortality
Participants' freedom from cardiovascular mortality. Time to events were estimated by Kaplan-Meier method.
Time frame
1-, 2-, 3-, 4-, and 5- Years follow-up4
Percentage of participant's freedom from valve-related mortality
Participants' freedom from valve-related mortality. Time to events were estimated by Kaplan-Meier method.
Time frame
1-, 2-, 3-, 4-, and 5- Years follow-upSponsors and contacts
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Source ClinicalTrials.gov
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