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

29 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

75

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Indiana
      • Carmel, Indiana, Stati Uniti, 46260
        • Ascension St. Vincent's Hospital
        • Investigatore principale:
          • David Heimansohn, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Edwards TRIFORMIS RESILIA heart valve
Subjects who were treated with the Edwards TRIFORMIS RESILIA heart valve
Dispositivo: Edwards TRIFORMIS RESILIA heart valve
Surgical replacement of the tricuspid valve with the Edwards TRIFORMIS RESILIA heart valve

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant's average mean gradient measurement over time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Edwards Lifesciences

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2030

Completamento dello studio (Stimato)

1 dicembre 2034

Date di iscrizione allo studio

Primo inviato

29 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-14

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be available to other researchers.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sedi

3
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