Heart Valve DiseasesTRIBLAZENCT07684313
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study)
An observational study of Heart Valve Diseases and Heart Diseases, run by Edwards Lifesciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- What is being tested?
- Edwards TRIFORMIS RESILIA heart valve
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2026to Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population includes adult candidates who require replacement of their native or prosthetic tricuspid valve.
Who may be able to join
- 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
Who cannot join
- Untreatable hypersensitivity to nitinol alloys (nickel and titanium)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascension St. Vincent's Hospital
Carmel, Indiana, 46260
David Heimansohn, MD
About this study
Official title: Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)
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.
Read the detailed description
Subjects in the TRIBLAZE study will be enrolled at up to 15 sites in the United States. The population will be participants requiring replacement of their native or prosthetic tricuspid valve.
- Being tested
- Edwards TRIFORMIS RESILIA heart valve
- Medical subject headings
- Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards TRIFORMIS RESILIA heart valveDevice
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve
| Study group | Role | What they receive |
|---|---|---|
| Edwards TRIFORMIS RESILIA heart valve | Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve Receives: Device: Edwards TRIFORMIS RESILIA heart valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
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.
Measured: 1 Year
Participant's right ventricular function over time
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.
Measured: 1 Year
Participant's amount of paravalvular leak over time
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.
Measured: 1 Year
Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 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.
Measured: Baseline and 1 Year
Secondary outcomes (10)
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.
Measured: Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from all cause mortality
Participants' freedom from all cause mortality. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from cardiovascular mortality
Participants' freedom from cardiovascular mortality. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related mortality
Participants' freedom from valve-related mortality. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from tricuspid valve reintervention
Participants' freedom from a reoperation on their tricuspid valve. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related pulmonary embolism
Participants' freedom from valve-related pulmonary embolism. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related valve thrombosis
Participants' freedom from valve-related valve thrombosis. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related hemorrhage
Participants' freedom from valve-related hemorrhage. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related endocarditis
Participants' freedom from valve-related endocarditis. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from tricuspid valve-related heart failure hospitalization
Participants' freedom from tricuspid valve-related heart failure hospitalization. Time to events were estimated by Kaplan-Meier method.
Measured: 1-, 2-, 3-, 4-, and 5- Years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start22 Sep 2026
- Primary completionAug 2030 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684313
- Sponsor's protocol ID
- 2025-14
- Acronym
- TRIBLAZE
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Single-arm, Observational Study Assessing Real-world Safety and Performance of the TRIFORMIS RESILIA Tricuspid Valve for Surgical Tricuspid Valve Replacement (TRIBLAZE Study)
- ClinicalTrials.gov ID
- NCT07684313
- Acronym / sponsor ID
- TRIBLAZE / 2025-14
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects in the TRIBLAZE study will be enrolled at up to 15 sites in the United States. The population will be participants requiring replacement of their native or prosthetic tricuspid valve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards TRIFORMIS RESILIA heart valve | – | Device: Edwards TRIFORMIS RESILIA heart valveSubjects who were treated with the Edwards TRIFORMIS RESILIA heart valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population includes adult candidates who require replacement of their native or prosthetic tricuspid valve.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Untreatable hypersensitivity to nitinol alloys (nickel and titanium)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards TRIFORMIS RESILIA heart valveSurgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve | Device | Edwards TRIFORMIS RESILIA heart valve |
Primary outcome
Participant's average mean gradient measurement over time
Time frame: 1 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 time
Time frame: 1 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 time
Time frame: 1 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 time
Time frame: 1 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 time
Time frame: 1 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 time
Time frame: 1 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 year
Time frame: Baseline 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.
10 secondary outcomes
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
Time frame: Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from all cause mortality
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from cardiovascular mortality
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related mortality
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from tricuspid valve reintervention
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related pulmonary embolism
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related valve thrombosis
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related hemorrhage
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from valve-related endocarditis
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Percentage of participant's freedom from tricuspid valve-related heart failure hospitalization
Time frame: 1-, 2-, 3-, 4-, and 5- Years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Heart Diseases, run by Edwards Lifesciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Westbrook, PhD (949-250-2500, Aya_Westbrook@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's average mean gradient measurement over time (time frame: 1 Year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.