Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-09 @ 7:24 AM
Study NCT ID:
NCT03258333
Status:
UNKNOWN
Last Update Posted:
2017-08-23
First Post:
2017-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Small Aortic Annulus - a New Solution to the Old Problem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-20', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-08-20', 'lastUpdatePostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age (years)', 'timeFrame': '12 months after surgery', 'description': 'Description and comparison of groups patients'}, {'measure': 'Body mass index, kg/m²', 'timeFrame': '12 months after surgery', 'description': 'Description and comparison of groups patients'}, {'measure': 'Body surface area, m²', 'timeFrame': '12 months after surgery', 'description': 'Description and comparison of groups patients'}, {'measure': 'Aortic annulus diameter, mm', 'timeFrame': '12 months after surgery', 'description': 'Description and comparison of groups patients'}, {'measure': 'Indexed aortic annulus diameter, mm/m²', 'timeFrame': '12 months after surgery', 'description': 'Description and comparison of groups patients'}, {'measure': 'Myocardial mass index, g/m²', 'timeFrame': '12 months after surgery', 'description': 'Assessment of reverse remodeling of the left ventricle'}], 'primaryOutcomes': [{'measure': 'Indexed effective orifice area, cm²/m²', 'timeFrame': '12 months after surgery', 'description': 'Assessment of aortic valve dimension'}], 'secondaryOutcomes': [{'measure': 'prosthesis-patient mismatch (PPM)', 'timeFrame': '12 months after surgery', 'description': 'Indicator of the effectiveness of aortic valve replacement'}, {'measure': 'Peak pressure gradient, mm.Hg', 'timeFrame': '12 months after surgery', 'description': 'Indicator of the effectiveness of aortic valve replacement'}, {'measure': 'Mean pressure gradient, mm.Hg', 'timeFrame': '12 months after surgery', 'description': 'Indicator of the effectiveness of aortic valve replacement'}, {'measure': 'Effective orifice area, EOA, cm²', 'timeFrame': '12 months after surgery', 'description': 'Assessment of aortic valve dimension'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aortic stenosis, aortic valve replacement, pericardium'], 'conditions': ['Aortic Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '16678590', 'type': 'BACKGROUND', 'citation': 'Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves. J Thorac Cardiovasc Surg. 2006 May;131(5):1058-64. doi: 10.1016/j.jtcvs.2005.12.034.'}, {'pmid': '25818901', 'type': 'RESULT', 'citation': 'Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Hagiwara S, Kiyohara N. Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis. Circ J. 2015;79(7):1504-10. doi: 10.1253/circj.CJ-14-1092. Epub 2015 Mar 30.'}, {'pmid': '21273254', 'type': 'RESULT', 'citation': 'Ozaki S, Kawase I, Yamashita H, Uchida S, Nozawa Y, Matsuyama T, Takatoh M, Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):550-3. doi: 10.1510/icvts.2010.253682. Epub 2011 Jan 27.'}, {'pmid': '17532395', 'type': 'RESULT', 'citation': 'Borger MA, Nette AF, Maganti M, Feindel CM. Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. Ann Thorac Surg. 2007 Jun;83(6):2054-8. doi: 10.1016/j.athoracsur.2007.02.062.'}, {'pmid': '27641297', 'type': 'RESULT', 'citation': 'Ghoneim A, Bouhout I, Demers P, Mazine A, Francispillai M, El-Hamamsy I, Carrier M, Lamarche Y, Bouchard D. Management of small aortic annulus in the era of sutureless valves: A comparative study among different biological options. J Thorac Cardiovasc Surg. 2016 Oct;152(4):1019-28. doi: 10.1016/j.jtcvs.2016.06.058. Epub 2016 Jul 28.'}, {'pmid': '27234223', 'type': 'RESULT', 'citation': 'Morita S. Aortic valve replacement and prosthesis-patient mismatch in the era of trans-catheter aortic valve implantation. Gen Thorac Cardiovasc Surg. 2016 Aug;64(8):435-40. doi: 10.1007/s11748-016-0657-9. Epub 2016 May 27.'}, {'pmid': '24818319', 'type': 'RESULT', 'citation': 'Minardi G, Pergolini A, Zampi G, Pulignano G, Pero G, Sbaraglia F, Pino PG, Cioffi G, Musumeci F. St. Jude Trifecta versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-echocardiography and hemodynamic performance. Monaldi Arch Chest Dis. 2013 Sep;80(3):126-32. doi: 10.4081/monaldi.2013.74.'}]}, 'descriptionModule': {'briefSummary': 'In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (\\<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)', 'detailedDescription': 'Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (\\<21 mm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with severe degenerative aortic stenosis and small aortic annulus (\\<21 mm) were enrolled in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe degenerative aortic valve stenosis\n\nExclusion Criteria:\n\n* redo operation, infective endocarditis'}, 'identificationModule': {'nctId': 'NCT03258333', 'briefTitle': 'Small Aortic Annulus - a New Solution to the Old Problem', 'organization': {'class': 'OTHER', 'fullName': 'The Federal Centre of Cardiovascular Surgery, Russia'}, 'officialTitle': 'Small Aortic Annulus - a New Solution to the Old Problem', 'orgStudyIdInfo': {'id': 'FederalCCS002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stented bioprosthesis', 'description': "Standard aortic valve replacement with stented bioprosthesis. Surgery is performed through median sternotomy, aortic and right or bicaval venous cannulation, normothermic perfusion, antegrade cardioplegia with use cardioplegic solution Custodiol. A transverse aortotomy was performed 1 to 2 cm above the right coronary artery. The aortic annulus was thoroughly débrided of calcium. Valve sizing was performed with standard manufacturers' sizers, with selection of the size that would comfortably fit within the aortic annulus. A noneverting suture technique was used in all patients with interrupted horizontal mattress 2-0 braided sutures placed around the aortic annulus, with the pledgets on the ventricular aspect.", 'interventionNames': ['Procedure: aortic valve replacement']}, {'label': 'Ozaki procedure', 'description': 'Aortic valve reconstruction using autologus pericardium (Ozaki procedure). The autologous pericardium is harvested after routine median sternotomy. Harvested pericardium is then treated with a 0.6% glutaraldehyde solution for 10 min and then rinsed 3 times with sterilized saline each time for 6 min. After resection of the diseased aortic valve cusps, the distance between each commissure is measured using a self-developed sizing instrument. Glutaraldehyde-treated autologous pericardium is trimmed with a self-developed template corresponding to the measured value. The annular margin of the pericardial leaflet is then running-sutured to each annulus with 3-0 monofilament sutures. Commissural coaptation is secured with additional 4-0 monofilament sutures. The coaptation of the 3 cusps is then checked with negative pressure on the left ventricular vent.', 'interventionNames': ['Procedure: aortic valve replacement']}], 'interventions': [{'name': 'aortic valve replacement', 'type': 'PROCEDURE', 'description': 'Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium', 'armGroupLabels': ['Ozaki procedure', 'Stented bioprosthesis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '440071', 'city': 'Penza', 'country': 'Russia', 'facility': 'FederalCCS', 'geoPoint': {'lat': 53.19568, 'lon': 45.01075}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Federal Centre of Cardiovascular Surgery, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Cardiovascular surgeon', 'investigatorFullName': 'Mikulyak Artur', 'investigatorAffiliation': 'The Federal Centre of Cardiovascular Surgery, Russia'}}}}