Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04816851
Status:
COMPLETED
Last Update Posted:
2025-01-20
First Post:
2021-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'aortic valve re intervention or aortic regurge', 'timeFrame': 'through one year', 'description': 'analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography'}, {'measure': 'LV dimensions and EF%.', 'timeFrame': 'through one year', 'description': 'Follow up Echocardiography data such as LV dimensions and EF%.'}], 'primaryOutcomes': [{'measure': 'aortic transvalvular gradient', 'timeFrame': 'at follow up frame through one year', 'description': 'analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'average 5-7 days', 'description': 'number of days spent'}, {'measure': 'number of patients developed complications', 'timeFrame': 'through one year', 'description': 'the study will be monitored for Endocarditis, thromboembolic manifestation, intracranial hemorrhage'}, {'measure': 'conduction disturbances', 'timeFrame': '6 months post operative', 'description': 'the patients will be monitored for arrhythmia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nPerforming hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .', 'detailedDescription': '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.\n\nOptions 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with AV disease.\n* Documented symptomatic moderate or greater aortic stenosis\n* small aortic annulus patients\n* A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.\n* 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.\n* Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.\n\nExclusion Criteria:\n\n* Patients with previous aortic valve surgery.\n* missing informed consent\n* Participation in another clinical research.'}, 'identificationModule': {'nctId': 'NCT04816851', 'briefTitle': 'Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases', 'orgStudyIdInfo': {'id': '17200559'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ozaki group', 'description': 'Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.', 'interventionNames': ['Procedure: OZAKI technique']}], 'interventions': [{'name': 'OZAKI technique', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Ozaki group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Ali Abd Elwahab, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist', 'investigatorFullName': 'Mohammed Emad El-Dein Omar', 'investigatorAffiliation': 'Assiut University'}}}}