Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-03-04 @ 12:00 PM
Study NCT ID:
NCT00614718
Status:
COMPLETED
Last Update Posted:
2008-02-13
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], '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'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1993-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-12', 'studyFirstSubmitDate': '2008-01-30', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to lead failure or lead failure recurrence', 'timeFrame': 'from inclution to death or end of follow up (Jan 2004)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Implantable cardioverter defibrillator', 'lead failure', 'pace/sense lead', 'ICD complication', 'inappropriate therapy', 'Defibrillators'], 'conditions': ['Death, Sudden, Cardiac', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil).\n\nThe two approaches compared are:\n\nReplacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.', 'detailedDescription': 'Therapy with an implantable cardioverter defibrillator (ICD) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy.\n\nIn case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the "shock"-part of the existing electrode is still functional.\n\nThere is no longterm outcome data comparing these two strategies. We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004. Incidence of lead failure, type of lead used, approach and outcome were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implantation of an ICD between 1993 and 2004\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00614718', 'briefTitle': 'Failure of Chronically Implanted Defibrillator Leads -Incidence and Management', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study', 'orgStudyIdInfo': {'id': 'USB01'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Total number of patients receiving an ICD between 1993 and 2004 and not having re interventions due to malfunctioning leads.'}, {'label': '2', 'description': 'Patients with ICD lead failure receiving a new ICD lead'}, {'label': '3', 'description': 'Patients with ICD lead failure but intact shock-coil of the ICD lead receiving only an additional pace/sense lead.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Herzzentrum Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Benjamin Franklin, Division of Cardiology,', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christian Sticherling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Dept. Cardiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christian Sticherling, MD', 'oldOrganization': 'University Hospital Basel, Division of Cardiology'}}}}