Status:

COMPLETED

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

Lead Sponsor:

Chelyabinsk Regional Clinical Hospital

Conditions:

Bioprosthesis Failure

Allograft

Eligibility:

All Genders

60-74 years

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 ...

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 valv...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

January 12 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 29 2025

Estimated Enrollment :

93 Patients enrolled

Trial Details

Trial ID

NCT07210541

Start Date

January 12 2017

End Date

September 29 2025

Last Update

October 7 2025

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