Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT00279968
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2006-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INSIGHTS ICD Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-01'}, 'lastUpdateSubmitDate': '2007-12-26', 'studyFirstSubmitDate': '2006-01-19', 'studyFirstSubmitQcDate': '2006-01-19', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-20', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['ICD', 'Registry', 'Ventricular tachycardia', 'Ventricular Fibrillation'], 'conditions': ['Ventricular Tachycardia', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients 18 years of age or older.\n* Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.\n* New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.\n\nExclusion Criteria:\n\n* Patients enrolled in a device study which effects programming and or treatment."}, 'identificationModule': {'nctId': 'NCT00279968', 'briefTitle': 'INSIGHTS ICD Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Investigating Significant ICD Heart Therapies Registry Study (INSIGHTS ICD Registry)', 'orgStudyIdInfo': {'id': '231'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ICD', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'city': 'Poway', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'city': 'Palm Beach Gardens', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'city': 'Panama City', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.15946, 'lon': -85.65983}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Crown Point', 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'United States', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'city': 'Pomona', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 39.47845, 'lon': -74.57516}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Minot', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'city': 'Langhorne', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.17455, 'lon': -74.92267}}, {'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'city': 'Fredericksburg', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}], 'overallOfficials': [{'name': 'Alfred Buxton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rhode Island Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}]}}}