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

Chelyabinsk Regional Clinical Hospital

Status: Completed

Conditions: Bioprosthesis Failure; Allograft

Treatments: Procedure: aortic valve/root replacement

Study type: Observational

Funder types: Other

Identifiers

NCT07210541

30092025

Details and patient eligibility

About

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.

Full 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

Enrollment: 93 patients

Sex: All

Ages: 60 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with degenerative aortic valve disease not emendable for aortic valve repair
• Elective surgery

Exclusion criteria

• Left ventricle ejection fraction less than 40%
• Redo surgery
• Indication for concomitant mitral valve replacement
• Aortic valve/root endocarditis
• Severe COPD
• Dialysis patients

Trial design

93 participants in 2 patient groups

Stented biological prosthesis

Description:

Patients who underwent aortic valve replacement with stented biological valve

Treatment:

Procedure: aortic valve/root replacement

Allograft aortic root replacement

Description:

Patients who underwent allograft aortic root replacement