Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-29 @ 1:11 PM
Study NCT ID:
NCT00858559
Status:
TERMINATED
Last Update Posted:
2017-08-04
First Post:
2009-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'whyStopped': 'Stopped due to low enrollment. Patients will be followed up for 3 months.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant adverse events, especially death, hospitalization, inadequate device therapies', 'timeFrame': '27 months'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '27 months'}, {'measure': 'Number of device follow-ups', 'timeFrame': '27 months'}, {'measure': 'Quality of life', 'timeFrame': '27 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Implantable cardioverter defibrillator', 'Remote monitoring', 'Follow-up'], 'conditions': ['Cardiac Pacing', 'Electric Countershock', 'Ventricular Tachyarrhythmia']}, 'descriptionModule': {'briefSummary': "Patients with implantable cardioverter defibrillators (ICDs) should undergo regular device follow-ups every 3 months, to verify proper ICD function. However, many follow-ups are uneventful, revealing no relevant changes related to the implanted device and in the patient's diagnostic and therapeutic status. For time and economic reasons, longer follow-up intervals are frequently used although they are not according to recommendations. This may increase the delay in detection of relevant changes in the disease and in deviations from optimal ICD therapy in the individual patients. In the newest ICDs, the essential parameters reflecting safety and appropriateness of ICD therapy (threshold, impedance, intracardiac electrogram, etc.) are transmitted via Home Monitoring on a daily basis, to an internet platform accessible by the attending physician.\n\nIn the present study, the investigators evaluate safety and efficacy of 12-month follow-up intervals in ICDs with Home Monitoring capability, as compared with conventional 3-month follow-up scheme."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for a single-chamber implantable cardioverter-defibrillator (ICD)\n\nExclusion Criteria:\n\n* Contraindication for ICD\n* Indication for dual-chamber ICD or cardiac resynchronization therapy'}, 'identificationModule': {'nctId': 'NCT00858559', 'acronym': 'ANVITE', 'briefTitle': 'Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotronik SE & Co. KG'}, 'officialTitle': 'Follow-up of Patients With Implantable Cardioverter Defibrillators by Home Monitoring (ANVITE)', 'orgStudyIdInfo': {'id': 'HS047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Home Monitoring', 'interventionNames': ['Device: Implantable cardioverter defibrillator with Home Monitoring function']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Home Monitoring not used', 'interventionNames': ['Device: Standard implantable cardioverter defibrillator']}], 'interventions': [{'name': 'Implantable cardioverter defibrillator with Home Monitoring function', 'type': 'DEVICE', 'otherNames': ['Lumax 500/540 VR-T', 'CardioMessenger (for Home Monitoring data transmission)'], 'description': 'Implantable cardioverter defibrillators can send data from its diagnostic and therapy memory via wireless Home Monitoring on a daily basis to an internet based platform, securely accessed by the attending physician', 'armGroupLabels': ['1']}, {'name': 'Standard implantable cardioverter defibrillator', 'type': 'DEVICE', 'otherNames': ['Lumax 500/540 VR-T'], 'description': 'Implantable cardioverter defibrillators used as standard devices without Home Monitoring', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40237', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Cardiology in Tangram House', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Stefan Perings, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology in Tangram House, Düsseldorf, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotronik SE & Co. KG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}