Status:
ACTIVE_NOT_RECRUITING
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
Lead Sponsor:
Chelyabinsk Regional Clinical Hospital
Conditions:
Allografts
Tricuspid Valve Insufficiency
Eligibility:
All Genders
18-70 years
Brief Summary
The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.
Detailed Description
Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other...
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 50%
Key Trial Info
Start Date :
September 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06196684
Start Date
September 29 2021
End Date
October 30 2026
Last Update
October 6 2025
Active Locations (1)
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1
Department of Cardiac Surgery
Chelyabinsk, Chelyabinsk Oblast, Russia, 454076