Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

Chelyabinsk Regional Clinical Hospital

Status

Enrolling

Conditions

Allograft

Tricuspid Valve Disease

Bioprosthesis

Treatments

Procedure: tricuspid valve replacement

Study type

Observational

Funder types

Other

Identifiers

NCT06591000

14012016

Details and patient eligibility

About

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.

Full 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 complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 40%