NCT04816851

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

Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 .

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 atherosclerotic degenerative processes, congenital anomalies, or rheumatic process. Aortic valve replacement is the gold standard in the treatment of patients with severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger patients (\<60 years) owing to longer life-time, whereas biological valves are used for elderly patients in order to evade oral anticoagulation. Options for aortic valve disease have improved in the last era including replacement, repair, and reconstructive options. A variety of creative techniques including leaflet extensions, neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty to repair valves have been officially become skilled at, specially in pediatric population . In adults, the introduction of trans-catheter aortic valve inserting now permits treatment of degenerative aortic stenosis in the oldest and the highest risk patients. However, surgical treatment choices for pediatric patients with complex congenital aortic valve disease stay restricted. In recent years, much attention has been given to the Ozaki procedure, 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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-30
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2021-03-25
• Last updated: 2025-01-20

Locations

1 site across 1 country: Egypt