Status:
RECRUITING
Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
Lead Sponsor:
Chelyabinsk Regional Clinical Hospital
Conditions:
Allograft
Bioprosthesis
Eligibility:
All Genders
18-70 years
Brief Summary
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 v...
Detailed 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 com...
Eligibility Criteria
Inclusion
- 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
- 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%
Key Trial Info
Start Date :
January 14 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 14 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06591000
Start Date
January 14 2016
End Date
June 14 2025
Last Update
September 19 2024
Active Locations (1)
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1
Department of Cardiac Surgery
Chelyabinsk, Russia