TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) (TRIBLAZE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Disease
• Intervention / Treatment: Device: Edwards TRIFORMIS RESILIA heart valve

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 Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Aya Westbrook, PhD; Phone Number: 949-250-2500; Email: Aya_Westbrook@edwards.com

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46260
      • Ascension St. Vincent's Hospital
      • Principal Investigator: David Heimansohn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population includes adult candidates who require replacement of their native or prosthetic tricuspid valve.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Edwards TRIFORMIS RESILIA heart valve; Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve	Device: Edwards TRIFORMIS RESILIA heart valve; Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline and 1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	1-, 2-, 3-, 4-, and 5- Years follow-up

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2025-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No