Ignite Creation Date:
2025-12-24 @ 12:25 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT01626261
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2012-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood (serum and plasma) urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interference threshold of the device in electromagnetic fields in V/m and/or µT', 'timeFrame': 'for every patient during one ambulant visit about 1 hour study examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorder of Cardiac Pacemaker System', 'Disorder of Implantable Defibrillator', 'Cardiac Arrhythmia']}, 'referencesModule': {'references': [{'pmid': '24163067', 'type': 'DERIVED', 'citation': 'Napp A, Joosten S, Stunder D, Knackstedt C, Zink M, Bellmann B, Marx N, Schauerte P, Silny J. Electromagnetic interference with implantable cardioverter-defibrillators at power frequency: an in vivo study. Circulation. 2014 Jan 28;129(4):441-50. doi: 10.1161/CIRCULATIONAHA.113.003081. Epub 2013 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'The number of active electrical cardiac implants such as internal cardioverter defibrillators (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the last two decades. This has been paralleled by an increase in the number of sources of electromagnetic fields in daily life and occupational circumstances.\n\nTo date it remains unclear whether patients are at risk of device failure when being subjected to these fields. There are currently no general guidelines available to help clinicians informing their patients about safety levels and behavior around these electromagnetic fields.\n\nThis study aims to identify the thresholds of safe use of these devices and potential failures under worst-case conditions in 50/60 Hz fields (i.e.\n\npower line frequency). Device implanted patients will be exposed to electric, magnetic and combined fields of different intensity at various device programming (e.g. nominal and maximum sensitivity). The results will show whether patients are safe in public or occupational environments, which medical relevant disturbances can occur and if a correlation exists between disturbances and device type or patients physique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'age between 18 and 80', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women between 18 and 80 years\n* Implantation of a Pacemaker (SM)-/ ICD-assembly at least four weeks ago\n* signed informed consent\n\nExclusion Criteria:\n\n* enduring addiction of implant\n* thyroid disease\n* electrolyte imbalance on the trial day\n* pregnancy and breastfeeding\n* acute myocardial infarction (\\<30 days)\n* Comorbidity, which complicates an emergency assistance, e.g. morbus bechterew, glaucoma, micturition disturbance'}, 'identificationModule': {'nctId': 'NCT01626261', 'acronym': 'FEMU', 'briefTitle': 'Examination of Implant´s Safety in an Electronic and Magnetic Field Environment', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Study of Provocation Concerning Implants´Safety in Electronic and Magnetic Fields in Their Environment', 'orgStudyIdInfo': {'id': '09-051'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cardiac pacemaker', 'interventionNames': ['Device: Magnetic and electric field´s impact on the implant']}], 'interventions': [{'name': 'Magnetic and electric field´s impact on the implant', 'type': 'DEVICE', 'otherNames': ['Examination'], 'description': "Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field", 'armGroupLabels': ['cardiac pacemaker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'Northrhine-Westfalia', 'country': 'Germany', 'facility': 'Universtiy Hospital RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Andreas Napp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Aachen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}