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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04816851
Collaborator
AL-Nas Hospital (Other)
1
Enrollment
1
Location
28
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: OZAKI technique

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases
Anticipated Study Start Date :
Mar 30, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

ArmIntervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. aortic transvalvular gradient [at follow up frame through one year]

    analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography

Secondary Outcome Measures

  1. Duration of hospitalization [average 5-7 days]

    number of days spent

  2. number of patients developed complications [through one year]

    the study will be monitored for Endocarditis, thromboembolic manifestation, intracranial hemorrhage

  3. conduction disturbances [6 months post operative]

    the patients will be monitored for arrhythmia

Other Outcome Measures

  1. aortic valve re intervention or aortic regurge [through one year]

    analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography

  2. LV dimensions and EF%. [through one year]

    Follow up Echocardiography data such as LV dimensions and EF%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Assiut universityAssiutEgypt

Sponsors and Collaborators

  • Assiut University
  • AL-Nas Hospital

Investigators

  • Principal Investigator: Ali Abd Elwahab, PHD, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Emad El-Dein Omar, specialist, Assiut University
ClinicalTrials.gov Identifier:
NCT04816851
Other Study ID Numbers:
  • 17200559
First Posted:
Mar 25, 2021
Last Update Posted:
Mar 25, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2021