Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-08 @ 7:42 PM
Study NCT ID:
NCT00619151
Status:
TERMINATED
Last Update Posted:
2011-11-16
First Post:
2008-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Barbara.mathews@sorin.com', 'phone': '512-435-3602', 'title': 'Barbara Mathews Director Clinical and Medical Affairs', 'organization': 'Sorin Group USA, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination due to low enrollment resulted in only 2 patients. Insufficient data for analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of hospital stay after surgery, an average of 4 days.', 'description': 'Adverse event information collected during hospital stay', 'eventGroups': [{'id': 'EG000', 'title': 'Top Hat Valve', 'description': 'CarboMedics Supra-annular Top Hat Valve', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'St.Jude Valve', 'description': 'St. Jude Medical Regent Valve', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effective Orifice Area (EOA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Top Hat Valve', 'description': 'CarboMedics Supra-annular Top Hat Valve'}, {'id': 'OG001', 'title': 'St.Jude Valve', 'description': 'St. Jude Medical Regent Valve'}], 'paramType': 'MEAN', 'timeFrame': '6 month evaluation', 'description': 'Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.', 'unitOfMeasure': 'cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis not performed due to study termination prior to analysis period.'}, {'type': 'PRIMARY', 'title': 'Aortic Mean Gradient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Top Hat Valve', 'description': 'CarboMedics Supra-annular Top Hat Valve'}, {'id': 'OG001', 'title': 'St.Jude Valve', 'description': 'St. Jude Medical Regent Valve'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis not performed due to study termination prior to analysis period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Top Hat Valve', 'description': 'CarboMedics Supra-annular Top Hat Valve'}, {'id': 'FG001', 'title': 'St.Jude Valve', 'description': 'St. Jude Medical Regent Valve'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Study terminated prior to followup', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Top Hat Valve', 'description': 'CarboMedics Supra-annular Top Hat Valve'}, {'id': 'BG001', 'title': 'St.Jude Valve', 'description': 'St. Jude Medical Regent Valve'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>= 18 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Previous values entered in error. Study records archived and not accessible.', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Study records archived and not accessible.', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study stopped due to lack of elegible patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-07', 'studyFirstSubmitDate': '2008-01-10', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-20', 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective Orifice Area (EOA)', 'timeFrame': '6 month evaluation', 'description': 'Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.'}, {'measure': 'Aortic Mean Gradient', 'timeFrame': '6 months', 'description': 'Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['aortic valve', 'heart valve', 'valve replacement', 'Valve disease'], 'conditions': ['Aortic Valve Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.\n\nExclusion Criteria:\n\n* Patients \\< 18 years of age\n* Emergency surgery\n* Pre-existing valve prosthesis\n* Aortic root replacement\n* Active endocarditis'}, 'identificationModule': {'nctId': 'NCT00619151', 'briefTitle': 'CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sorin Group USA, Inc.'}, 'officialTitle': 'A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.', 'orgStudyIdInfo': {'id': 'RVSS-1H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'CarboMedics Supra-annular Top Hat Valve', 'interventionNames': ['Device: Top Hat']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'St. Jude Medical Regent Valve', 'interventionNames': ['Device: Regent']}], 'interventions': [{'name': 'Top Hat', 'type': 'DEVICE', 'description': 'Implant of CarboMedics Top Hat mechanical valve.', 'armGroupLabels': ['1']}, {'name': 'Regent', 'type': 'DEVICE', 'description': 'Implant of the St. Jude Medical Regent mechanical valve', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wellmont Holston Valley Medical Center', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sorin Group USA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}