NCT06591000

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

Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 56 (estimated)
• Sponsor: Chelyabinsk Regional Clinical Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Allograft
• Bioprosthesis
• Tricuspid Valve Disease

Interventions

Type	Name	Description
PROCEDURE	tricuspid valve replacement	Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Timeline

• Start date: 2016-01-14
• Primary completion: 2024-12-14
• Completion: 2025-06-14
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Russia