Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-14 @ 7:21 AM
Study NCT ID:
NCT02362802
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2015-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocardial Minimal Damage After Rapid Ventricular Pacing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017147', 'term': 'Defibrillators, Implantable'}], 'ancestors': [{'id': 'D047548', 'term': 'Defibrillators'}, {'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D004567', 'term': 'Electrodes, Implanted'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2015-02-01', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High sensitive Troponin', 'timeFrame': '14-20 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Antitachycardia Pacing']}, 'referencesModule': {'references': [{'pmid': '32179792', 'type': 'RESULT', 'citation': 'Semmler V, Deutschmann C, Haller B, Lennerz C, Brkic A, Grebmer C, Blazek P, Weigand S, Karch M, Busch S, Kolb C. Myocardial Minimal Damage After Rapid Ventricular Pacing - the prospective randomized multicentre MyDate-Trial. Sci Rep. 2020 Mar 16;10(1):4753. doi: 10.1038/s41598-020-61625-8.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive TroponinT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.\n\nExclusion Criteria:\n\n* Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated\n* Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation\n* Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing\n* Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation\n* Right sided implantation of ICD\n* Planned electrical cardioversion\n* Lead explantation or -extraction during procedure\n* Redo procedure (except of additional implantation of a right ventricular ICD lead)\n* Present temporary pacemaker electrode\n* ASA \\>= IV or NYHA IV\n* Cardiogenic shock\n* Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks\n* Lack of consent of patient\n* Minority of patient'}, 'identificationModule': {'nctId': 'NCT02362802', 'acronym': 'MyDate', 'briefTitle': 'Myocardial Minimal Damage After Rapid Ventricular Pacing', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Myocardial Minimal Damage After Rapid Ventricular Pacing', 'orgStudyIdInfo': {'id': 'GER-EP-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antitachycardia Pacing', 'description': 'Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care.', 'interventionNames': ['Device: Implantable Cardioverter Defibrillator']}, {'type': 'NO_INTERVENTION', 'label': 'No Antitachycardia Pacing', 'description': 'Implantable cardioverter defibrillator placement without Antitachycardia Pacing.\n\nApart from that usual standard of care.'}], 'interventions': [{'name': 'Implantable Cardioverter Defibrillator', 'type': 'DEVICE', 'armGroupLabels': ['Antitachycardia Pacing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Muenchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Christof Kolb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. C. Kolb', 'investigatorFullName': 'Adnan Kastrati, MD', 'investigatorAffiliation': 'Deutsches Herzzentrum Muenchen'}}}}