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Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Recruiting
18-70 years
All
Phase N/A

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Overview

The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.

Description

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Eligibility

Inclusion Criteria:

  • Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
    • Intraoperative findings suggested for tricuspid valve replacement rather than repair.

Exclusion Criteria:

  • Pregnancy
    • Confirmed active drug addiction
    • Progressive HIV-infection
    • HIV-infected patients with CD4-cells count less than 250
    • Patients with secondary tricuspid valve pathology (left-sided valve disease)
    • LV Ejection fraction less than 40%

Study details
    Allograft
    Bioprosthesis
    Tricuspid Valve Disease

NCT06591000

Chelyabinsk Regional Clinical Hospital

14 October 2025

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