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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816851
• Other study ID #: 17200559
• Status: Recruiting
• Start date: March 30, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: Mohammed Emad Eldin Omar
• Phone: 02010065327099
• Email: mhmd_rabab[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Patients with previous aortic valve surgery.

• missing informed consent

• Participation in another clinical research.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Defects, Congenital
• Heart Valve Diseases

Intervention

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.

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	AL-Nas Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	aortic valve re intervention or aortic regurge	analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography	through one year
Other	LV dimensions and EF%.	Follow up Echocardiography data such as LV dimensions and EF%.	through one year
Primary	aortic transvalvular gradient	analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography	at follow up frame through one year
Secondary	Duration of hospitalization	number of days spent	average 5-7 days
Secondary	number of patients developed complications	the study will be monitored for Endocarditis, thromboembolic manifestation, intracranial hemorrhage	through one year
Secondary	conduction disturbances	the patients will be monitored for arrhythmia	6 months post operative