Allografts, Tricuspid Valve Insufficiency
Conditions
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.
Interventions
PROCEDUREMitral allograft implantation
Tricuspid valve replacement with mitral valve allograft
Sponsors
Chelyabinsk Regional Clinical Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality (all cause and valve-related) | 30-day period | Estimate rate of mortality (all cause and valve-related) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic events | 30-day period | any neurological events in 30-day period |
| Bleeding and transfusions | 30 days | Freedom from major bleeding events |
| Cardiac structural complications | 30 days | any structural cardiac complication |
| Acute kidney injury | 30 days | freedom from type 3-4 AKI |
| Allograft valve dysfunction | 30 days | freedom from allograft valve stenosis or regurgitation |
Countries
Russia
Outcome results
None listed