Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-23 @ 1:05 AM
Study NCT ID:
NCT00848835
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2009-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Integrity Follow-up Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-30', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['defibrillator'], 'conditions': ['Sudden Cardiac Death']}, 'descriptionModule': {'briefSummary': 'To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.', 'detailedDescription': 'There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients who are indicated for a market released ICD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals\n\nExclusion Criteria:\n\n* Patients enrolled in other studies, not available for follow-up, \\< 18 yrs, unable to sign consent, life expectancy \\< 1 year due to a medical condition'}, 'identificationModule': {'nctId': 'NCT00848835', 'acronym': 'LEAD LIFE', 'briefTitle': 'Long Term Integrity Follow-up Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guidant Corporation'}, 'officialTitle': 'Long Term Integrity Follow-up Evaluation', 'orgStudyIdInfo': {'id': 'LEAD LIFE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control', 'description': 'all patients in the control group', 'interventionNames': ['Device: defibrillation lead (ENDOTAK EZ and RELIANCE)']}], 'interventions': [{'name': 'defibrillation lead (ENDOTAK EZ and RELIANCE)', 'type': 'DEVICE', 'description': 'defibrillation lead', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lawrence Sterns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Victoria Cardiac Arrythmia trials'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guidant Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anne Swearingen', 'oldOrganization': 'Boston Scientific'}}}}