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OpenTrials
Completed

NCT Number: NCT07210541

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

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.

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Key information

Conditions

Bioprosthesis Failure Allograft

Age range

60 year–74 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aortic valve/root replacement

Procedure

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

Primary outcomes

  1. Mortality

    Time frame: 30 days

    Early cardio-vascular mortality

Secondary outcomes

  1. Mortality

    Time frame: 2 years

    Cardio-vascular mortality

  2. Mortality

    Time frame: 2 years

    All-cause mortality

  3. Structural valve deterioration

    Time frame: 2 years

    New onset aortic regurgitation (vc >0,6) or escalated mean pressure gradient over 20 mmHg.

  4. Stroke

    Time frame: 2 years

    Ischemic stroke

  5. Reoperation

    Time frame: 2 years

    Reoperation for valve failure

  6. Endocarditis

    Time frame: 2 years

    Prosthetic valve endocarditis

Sponsors and collaborators

Lead sponsor

Chelyabinsk Regional Clinical Hospital

Other Gov

Registry information

Official study title

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.

Acronym: BIOCHOICE

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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