Status:

ACTIVE_NOT_RECRUITING

Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)

Lead Sponsor:

Maria Cecilia Hospital

Conditions:

Aortic Valve Disease

Eligibility:

All Genders

18+ years

Brief Summary

The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In t...

Eligibility Criteria

Inclusion

  • severe aortic valve stenosis or insufficiency
  • Written informed consent
  • Willingness to carry out the follow-up visits

Exclusion

  • Other types of aortic valve surgery

Key Trial Info

Start Date :

June 6 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 6 2027

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05411055

Start Date

June 6 2021

End Date

June 6 2027

Last Update

August 28 2024

Active Locations (1)

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MCH

Cotignola, Ravenna, Italy, 48033