Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 7:24 PM
Study NCT ID:
NCT01117792
Status:
COMPLETED
Last Update Posted:
2021-07-02
First Post:
2010-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.stoltz@bsci.com', 'phone': '1-800-227-3422', 'title': 'Tom Stoltz, Clinical Trial Manager', 'organization': 'Boston Scientific'}, 'certainAgreement': {'otherDetails': "Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThere is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'S-ICD System', 'description': 'Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 4, 'seriousNumAtRisk': 55, 'deathsNumAffected': 1, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Other - Adverse Event Terms Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Other - Adverse Event Terms Unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Conversion of Induced Ventricular Fibrillation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'S-ICD System', 'description': 'Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Testing done during the implant procedure', 'description': 'The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Investigator induce sustained ventricular fibrillation conversion efficacy. Two of the 55 subjects implanted did not induce sustained ventricular fibrillation leaving 53 evaluable subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'S-ICD System', 'description': 'Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'S-ICD System', 'description': 'Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.1', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'European', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'New Zealander, European', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Maori', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Subjects enrolled and implanted with a Cameron Health subcutaneous implantable cardioverter defibrillator (S-ICD) system.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-01', 'studyFirstSubmitDate': '2010-04-28', 'resultsFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-01', 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion of Induced Ventricular Fibrillation', 'timeFrame': 'Testing done during the implant procedure', 'description': 'The total number of subjects the S-ICD System was successful at converting induced sustained ventricular fibrillation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ACC/AHA/NASPE Class 1, IIa or IIb Indications']}, 'referencesModule': {'references': [{'pmid': '26148819', 'type': 'DERIVED', 'citation': 'Theuns DA, Crozier IG, Barr CS, Hood MA, Cappato R, Knops RE, Maass AH, Boersma LV, Jordaens L. Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1159-63. doi: 10.1161/CIRCEP.115.002953. Epub 2015 Jul 6.'}]}, 'descriptionModule': {'briefSummary': "The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Replacement of an existing implanted transvenous ICD system\n* Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system\n* Age is \\>= 18 years\n* Appropriate pre-operative ECG as measured with a specially developed template\n\nExclusion Criteria:\n\n* Subjects unable or unwilling to provide informed consent\n* Any condition which precludes the subject's ability to comply with the study requirements\n* Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study\n* Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.\n* Patients with a serious medical condition and life expectancy of less than one year.\n* Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing\n* Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant\n* Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR \\<= 29."}, 'identificationModule': {'nctId': 'NCT01117792', 'briefTitle': 'Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation', 'orgStudyIdInfo': {'id': 'DN-01040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S-ICD System', 'interventionNames': ['Device: subcutaneous implantable defibrillator (S-ICD) system']}], 'interventions': [{'name': 'subcutaneous implantable defibrillator (S-ICD) system', 'type': 'DEVICE', 'description': 'implantable defibrillator system', 'armGroupLabels': ['S-ICD System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '1100 DD', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1001', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8002', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}], 'overallOfficials': [{'name': "Stephen O'Connor, PhD, Hon FRCP", 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}