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

NCT07684313 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025-14
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Valve Diseases; Heart Diseases; Tricuspid Valve Disease; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class

  Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up

• Percentage of participant's freedom from all cause mortality

  1-, 2-, 3-, 4-, and 5- Years follow-up

• Percentage of participant's freedom from cardiovascular mortality

  1-, 2-, 3-, 4-, and 5- Years follow-up

• Percentage of participant's freedom from valve-related mortality

  1-, 2-, 3-, 4-, and 5- Years follow-up

• Percentage of participant's freedom from tricuspid valve reintervention

  1-, 2-, 3-, 4-, and 5- Years follow-up

Study Arms (1)

Edwards TRIFORMIS RESILIA heart valve

Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve

Device: Edwards TRIFORMIS RESILIA heart valve

Interventions

Edwards TRIFORMIS RESILIA heart valve DEVICE

Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Edwards TRIFORMIS RESILIA heart valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Untreatable hypersensitivity to nitinol alloys (nickel and titanium)

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

Ascension St. Vincent's Hospital

Carmel, Indiana, 46260, United States

Location

MeSH Terms

Conditions

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Aya Westbrook, PhD

CONTACT

949-250-2500; Aya_Westbrook@edwards.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): December 1, 2034
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)