Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-03 @ 8:42 PM
Study NCT ID:
NCT00559559
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAtient NOtifier Feature for Reduction of Anxiety
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in device related anxiety, related to battery depletion, as assessed by the Duru Questionnaire (question 9) Reduction in device related anxiety, related to device malfunction, as assessed by the Duru Questionnaire (question 10)', 'timeFrame': '12months'}], 'secondaryOutcomes': [{'measure': 'Reduction in general anxiety Evolution over time in anxiety for the different personality types Cross-overs Sensitivity and Specificity of the Patient Notifier™ Number of appropriate/inappropriate ICD therapies Hospitalizations Mortality', 'timeFrame': '1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary and secondary prevention for ventricular tachycardia'], 'conditions': ['Tachycardia, Ventricular']}, 'referencesModule': {'references': [{'pmid': '20207746', 'type': 'DERIVED', 'citation': 'Duru F, Dorian P, Favale S, Perings C, Pedersen SS, Willems V; PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study investigators. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. Europace. 2010 May;12(5):726-30. doi: 10.1093/europace/euq026. Epub 2010 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'This study is intended to look at the effect of the SJM vibrating Patient Notifier™ system, which will warn the patient of possible failures of the implanted system, on reducing patient device related anxiety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has recently (min. 2 weeks - max. 14 weeks) been implanted with an SJM ICD with the Patient Notifier™ feature;\n* Patient is willing and able to independently comprehend and complete the study-related questionnaires;\n* Patient has signed the study specific informed consent form.\n\nExclusion Criteria:\n\n* have already had a Patient Notifier™ alert since implant;\n* had a prior device implant (PM or ICD);\n* have not been discharged from the hospital since device implant;\n* have evidence of psychosis, dementia or cognitive impairment as documented in the patients' hospital records;\n* cannot commit to the follow-up schedule;\n* have a life expectancy of less than 1 year;\n* are on a waiting list for a heart transplant;\n* are less than 18 years old;\n* are pregnant;"}, 'identificationModule': {'nctId': 'NCT00559559', 'acronym': 'Panoramic', 'briefTitle': 'PAtient NOtifier Feature for Reduction of Anxiety', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'PAtient NOtifier Feature for Reduction of Anxiety: A Multicenter ICD Study', 'orgStudyIdInfo': {'id': 'CR06002HV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': 'Patient Notifier turned OFF', 'interventionNames': ['Device: ICD implant + Patient Notifier turned OFF']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Patient Notifier turned ON', 'interventionNames': ['Procedure: ICD Implant + Patient Notifier turned ON']}], 'interventions': [{'name': 'ICD implant + Patient Notifier turned OFF', 'type': 'DEVICE', 'description': 'ICD implant, plus standard care, i.e. Patient Notifier turned off', 'armGroupLabels': ['Control Group']}, {'name': 'ICD Implant + Patient Notifier turned ON', 'type': 'PROCEDURE', 'description': 'ICD implant. The Patient Notifier™ feature will be turned ON.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Firat Duru, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsspital Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}