About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Confirmed active drug addiction
Progressive HIV-infection
HIV-infected patients with CD4-cells count less than 250
Trial population
Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
Trial design
Case-control
Retrospective
Treatments tested in this trial
tricuspid valve replacement
Procedure/SurgeryComplete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis
Treatment groups
Trial outcomes
Primary outcomes
Mortality
Freedom from all-cause mortality (%)
Stroke
Stroke rate (n,%)
Severe valve dysfunction
Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)
Freedom from prosthetic endocarditis
Number of patients free from prosthetic endocarditis (n,%)
Secondary outcomes
Transvalvular gradient
Peak and mean gradient (mmHg)
Transprosthetic regurgitation
Vena contracta (mm)
Right atrial remodeling
right atrium size (mm)
Sponsors and contacts
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