Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT03526302
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-03', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High sensitive TroponinT', 'timeFrame': '24 hours', 'description': 'Difference between pre- and postoperative high sensitive TroponinT serum levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sudden Cardiac Death']}, 'referencesModule': {'references': [{'pmid': '32959177', 'type': 'RESULT', 'citation': "Weigand S, O'Connor M, Blazek P, Kantenwein V, Friedrich L, Grebmer C, Schaarschmidt C, von Olshausen G, Reents T, Deisenhofer I, Lennerz C, Kolb C. Release of high-sensitive TROPonin T by implantation of an entirely subcutaneous Implantable Cardioverter-defibrillator compared to a conventional transvenous approach: the TROPIC registry. J Interv Card Electrophysiol. 2021 Oct;62(1):75-81. doi: 10.1007/s10840-020-00874-z. Epub 2020 Sep 21."}]}, 'descriptionModule': {'briefSummary': 'Serum Troponin levels pre- and postoperatively will be compared in patients receiving an entirely subcutaneous cardioverter-defibrillator.', 'detailedDescription': 'To analyze the periprocedural myocardial damage the pre- and postoperative assessment of serum levels of high sensitive TroponinT (hsTnT) is done. The main objectives of the TROPIC register are to evaluate the level of high sensitive TroponinT before and after S-ICD device implantation and to compare these changes in TroponinT-levels with those after standard transvenous ICD-implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the indication for the implantation of an entirely subcutaneous cardioverter-defibrillator', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for the implantation of an entirely subcutaneous cardioverter-defibrillator\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03526302', 'acronym': 'TROPIC', 'briefTitle': 'TroponinT After Subcutaneous Cardioverter-Defibrillator Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Register About Change of hsTROPoninT After Implantation of a Subcutaneous Implantable Cardioverter-Defibrillator', 'orgStudyIdInfo': {'id': 'GER-EP-018'}}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Christof Kolb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}