Status:

COMPLETED

Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases

Lead Sponsor:

Assiut University

Conditions:

Aortic Valve Disease

Eligibility:

All Genders

Brief Summary

Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients. ...

Detailed Description

Heart valve disease signifies a severe growing public health problem in developing countries, with aortic valve stenosis being the most common issue. Heart valve disease is commonly initiated by ather...

Eligibility Criteria

Inclusion

  • Subject with AV disease.
  • Documented symptomatic moderate or greater aortic stenosis
  • small aortic annulus patients
  • A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
  • Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
  • Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.

Exclusion

  • Patients with previous aortic valve surgery.
  • missing informed consent
  • Participation in another clinical research.

Key Trial Info

Start Date :

March 30 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 30 2023

Estimated Enrollment :

1 Patients enrolled

Trial Details

Trial ID

NCT04816851

Start Date

March 30 2021

End Date

July 30 2023

Last Update

January 20 2025

Active Locations (1)

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Assiut university

Asyut, Egypt