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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07210541

Acronym

BIOCHOICE

Enrollment

Registered

2025-10-07

Start date

2017-01-12

Completion date

2025-09-29

Last updated

2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft, Bioprosthesis Failure

Keywords

aortic valve, bioprosthesis, allograft

Brief 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

Interventions

PROCEDUREaortic valve/root replacement

Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mortality	30 days	Early cardio-vascular mortality

Secondary

Measure	Time frame	Description
Mortality	2 years	Cardio-vascular mortality
Structural valve deterioration	2 years	New onset aortic regurgitation (vc \>0,6) or escalated mean pressure gradient over 20 mmHg.
Stroke	2 years	Ischemic stroke
Reoperation	2 years	Reoperation for valve failure
Endocarditis	2 years	Prosthetic valve endocarditis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026