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

NCT04816851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-01-20

No results posted yet for this study

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. A very promising technique with the potential benefits of dodging oral anticoagulation, foreign material, and suitable for patients with small aortic annuli and in infectious endocarditis.

Performing hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .

Conditions

  • Aortic Valve Disease

Interventions

PROCEDURE

OZAKI technique

an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Ali Abd Elwahab, PHD · Assiut University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2023-06-30
Completion
2023-07-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816851 on ClinicalTrials.gov