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

29. juni 2026 opdateret af: Edwards Lifesciences

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

75

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Indiana
      • Carmel, Indiana, Forenede Stater, 46260
        • Ascension St. Vincent's Hospital
        • Ledende efterforsker:
          • David Heimansohn, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Edwards TRIFORMIS RESILIA heart valve
Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve
Enhed: Edwards TRIFORMIS RESILIA heart valve
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's average mean gradient measurement over time
Tidsramme: 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.
1 Year
Participant's average peak gradient measurement over time
Tidsramme: 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.
1 Year
Participant's average Effective Orifice Area (EOA) measurement over time
Tidsramme: 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.
1 Year
Participant's amount of tricuspid valvular regurgitation measurement over time
Tidsramme: 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.
1 Year
Participant's right ventricular function over time
Tidsramme: 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.
1 Year
Participant's amount of paravalvular leak over time
Tidsramme: 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.
1 Year
Participant's quality of life improvement as measured on the Kansas City Cardiomyopathy Questionnaire from baseline to 1 year
Tidsramme: 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.
Baseline and 1 Year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
Tidsramme: Baseline, 1 month, 1-, 2-, 3-, 4-, and 5- Years follow-up

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Edwards Lifesciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2030

Studieafslutning (Anslået)

1. december 2034

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be available to other researchers.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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