Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 11:52 PM
Study NCT ID:
NCT03521050
Status:
RECRUITING
Last Update Posted:
2020-09-04
First Post:
2017-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LUKS-Leads Registry on Long-term Performance of ICD Leads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098523', 'term': 'Device Lead Extraction'}], 'ancestors': [{'id': 'D020878', 'term': 'Device Removal'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance of lead impedance', 'timeFrame': 'regular clinical controls within 10 years', 'description': 'electronic impedances in Ω'}, {'measure': 'performance of lead threshold', 'timeFrame': 'during regular clinical controls within 10 years', 'description': 'threshold values in V'}, {'measure': 'performance of lead sensing', 'timeFrame': 'during regular clinical controls within 10 years', 'description': 'sensing values in millivolt (mV)'}, {'measure': 'lead parameters', 'timeFrame': 'during regular clinical controls within 10 years', 'description': 'battery performance in %'}, {'measure': 'performance of defibrillator', 'timeFrame': 'during regular clinical controls within 10 years', 'description': 'inadequate/adequate shock release in numbers'}, {'measure': 'control system of defibrillator', 'timeFrame': 'during regular clinical controls within 10 years', 'description': 'software problems in numbers and descriptive'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Defibrillators', 'Electrical Shock']}, 'descriptionModule': {'briefSummary': 'All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.', 'detailedDescription': 'All patients having an ICD implanted and having follow-up at the investigators center are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.\n\nThe following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a clinical indication for an ICD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients being implanted with a Defibrillator lead from 2006 onwards\n\nExclusion Criteria:\n\n* documented refusal of data collection for scientific purposes'}, 'identificationModule': {'nctId': 'NCT03521050', 'briefTitle': 'LUKS-Leads Registry on Long-term Performance of ICD Leads', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'LUKS-Leads Registry on Long-term Performance of ICD Leads', 'orgStudyIdInfo': {'id': '2016-02002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'implanted defibrillator lead', 'description': 'patients having an ICD implanted and having follow-up at the investigators center', 'interventionNames': ['Device: defibrillator lead']}], 'interventions': [{'name': 'defibrillator lead', 'type': 'DEVICE', 'description': 'observation of long-term performance of defibrillator leads', 'armGroupLabels': ['implanted defibrillator lead']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Richard Kobza, MD', 'role': 'CONTACT', 'email': 'richard.kobza@luks.ch', 'phone': '+41412055144'}], 'facility': 'Luzerner Heart Centre', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'centralContacts': [{'name': 'Richard Kobza, MD', 'role': 'CONTACT', 'email': 'richard.kobza@luks.ch', 'phone': '+41412055144'}, {'name': 'Brigitta Mehmann, PHD', 'role': 'CONTACT', 'email': 'brigitta.mehmann@luks.ch', 'phone': '+41412052455'}], 'overallOfficials': [{'name': 'Richard Kobza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luzerner Kantonsspital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Richard Kobza', 'investigatorAffiliation': 'Luzerner Kantonsspital'}}}}