Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery (ESEMATS)

Chelyabinsk Regional Clinical Hospital

Status: Active, not recruiting

Conditions: Allografts; Tricuspid Valve Insufficiency

Treatments: Procedure: Mitral allograft implantation

Study type: Observational

Funder types: Other

Identifiers

NCT06196684

26122023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 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 50%

Trial design

30 participants in 1 patient group

Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement

Treatment:

Procedure: Mitral allograft implantation