Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-04-03 @ 8:01 AM
Study NCT ID:
NCT03677804
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2018-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2018-09-11', 'studyFirstSubmitQcDate': '2018-09-18', 'lastUpdatePostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in aortic transvalvular gradient measured by transthoracic echocardiography', 'timeFrame': 'From Baseline (end of cardiac surgery) until 12 months after cardiac surgery', 'description': 'Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'occurence of death', 'timeFrame': 'From Baseline (end of cardiac surgery) until 12 months after cardiac surgery', 'description': 'Change in clinical Parameter: death'}, {'measure': 'occurence of cardiac re-surgery', 'timeFrame': 'From Baseline (end of cardiac surgery) until 12 months after cardiac surgery', 'description': 'Change in clinical parameter: cardiac re-surgery'}, {'measure': 'occurence of stroke', 'timeFrame': 'From Baseline (end of cardiac surgery) until 12 months after cardiac surgery', 'description': 'Change in clinical parameter: stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic valve reconstruction', 'OZAKI technique', 'autologous pericardium'], 'conditions': ['Aortic Valve Disease']}, 'referencesModule': {'references': [{'pmid': '32458022', 'type': 'DERIVED', 'citation': 'Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.', 'detailedDescription': 'The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) in Universitätsspital Basel/ Switzerland since September 2015.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aortic valve reconstruction using autologous Pericardium (OZAKI technique)\n\nExclusion Criteria:\n\n* missing informed consent'}, 'identificationModule': {'nctId': 'NCT03677804', 'briefTitle': 'Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the OZAKI Technique', 'orgStudyIdInfo': {'id': '2017-00556; ch17Reuthebuch'}}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Herzchirurgie University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Oliver Reuthebuch, PD Dr. med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}