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

NCT04816851 | Completed DMC

• 1 other identifier: 17200559
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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. 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

Outcome Measures

Primary Outcomes (1)

• aortic transvalvular gradient

  analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography

  at follow up frame through one year

Secondary Outcomes (3)

• Duration of hospitalization

  average 5-7 days

• number of patients developed complications

  through one year

• conduction disturbances

  6 months post operative

Other Outcomes (2)

• aortic valve re intervention or aortic regurge

  through one year

• LV dimensions and EF%.

  through one year

Study Arms (1)

Ozaki group

Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.

Procedure: OZAKI technique

Interventions

OZAKI technique 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.

Ozaki group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ali Abd Elwahab, PHD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: March 30, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

EG (1)