NCT06196684
Active, Not Recruiting
N/A
Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement
Chelyabinsk Regional Clinical Hospital1 site in 1 country30 target enrollmentSeptember 29, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Allografts
- Sponsor
- Chelyabinsk Regional Clinical Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mortality (all cause and valve-related)
- Status
- Active, Not Recruiting
- Last Updated
- 6 months ago
Overview
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 valve related complication ) is going to be evaluated.
Investigators
Mikhail Nuzhdin
Director
Chelyabinsk Regional Clinical Hospital
Eligibility Criteria
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 50%
Outcomes
Primary Outcomes
Mortality (all cause and valve-related)
Time Frame: 30-day period
Estimate rate of mortality (all cause and valve-related)
Secondary Outcomes
- Cardiac structural complications(30 days)
- Acute kidney injury(30 days)
- Allograft valve dysfunction(30 days)
- Neurologic events(30-day period)
- Bleeding and transfusions(30 days)
Study Sites (1)
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