NCT07210541

Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease

Safety, Clinical Efficacy and Time-to-event Survival in Patients With Degenerative Aortic Valve Disease Scheduled for Stented Biological Aortic Valve Replacement Versus Allograft Aortic Root Replacement.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Chelyabinsk Regional Clinical Hospital · Other Government
• Sex: All
• Age: 60 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.

Detailed description

Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation

Conditions

• Bioprosthesis Failure
• Allograft

Interventions

Type	Name	Description
PROCEDURE	aortic valve/root replacement	Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft

Timeline

• Start date: 2017-01-12
• Primary completion: 2024-06-30
• Completion: 2025-09-29
• First posted: 2025-10-07
• Last updated: 2025-10-07