Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:39 AM
Study NCT ID:
NCT07360158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-01-14', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CorSky-related SADE-d free rate at 6 months', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tachyarrhythmia', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock\\_BC (Ilivia Neo, Intica Neo) implant and programmer software features.\n\nThe new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky).\n\nThe goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Standard indication for ICD or CRT-D', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Standard indication for ICD or CRT-D therapy according to clinical guidelines\n* Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker\n* Ability to understand the nature of the study.\n* Ability and willingness to perform all on-site follow-up visits at the study site.\n* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept.\n\nExclusion Criteria:\n\n* For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia\n* For VR-T DX and CRT-DX: Patients requiring atrial pacing\n* Planned for His-Bundle-Pacing\n* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months\n* Pregnant or breast feeding.\n* Age less than 18 years.\n* Participation in an interventional clinical investigation in parallel to this study. ,\n* Life-expectancy less than 12 months.'}, 'identificationModule': {'nctId': 'NCT07360158', 'briefTitle': 'BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Post-market Study for the CorSky Family of ICDs', 'orgStudyIdInfo': {'id': 'TA121'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CorSky ICD or CRT-D', 'type': 'DEVICE', 'description': 'Subjects with an indication for an ICD or CRT-D device will be implanted with a CorSky device of the CorSky ICD family according to standard implantation procedures. Device programming will be done according to the medical needs of the subjects.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}