Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-26 @ 8:44 PM
Study NCT ID:
NCT01626768
Status:
COMPLETED
Last Update Posted:
2013-07-17
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medtronic Market-Released DF4 Lead Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'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': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-16', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In vivo lead shape', 'timeFrame': 'Six Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tachycardia']}, 'descriptionModule': {'briefSummary': 'The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.\n\nThe purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed at participating centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients greater than 18 years of age.\n* Patients able and willing to attend imaging session.\n* Patients able and willing to give informed consent.\n* Patients with an implanted device/lead(s) for a minimum of 3 months.\n\nExclusion Criteria:\n\n* Subjects who require a legally authorized representative to obtain consent.\n* Subjects with exclusion criteria required by local law (e.g. age, breastfeeding\n* Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control.'}, 'identificationModule': {'nctId': 'NCT01626768', 'briefTitle': 'Medtronic Market-Released DF4 Lead Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'orgStudyIdInfo': {'id': 'DF4-Imaging-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}