Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-03-23 @ 6:45 PM
Study NCT ID:
NCT02849769
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2016-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
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', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10979}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.', 'timeFrame': 'up to 5 years post-approval.', 'description': 'The primary objective will be analyzed and reported when 50 patients with a true VF episode following MR exposure have been identified'}], 'secondaryOutcomes': [{'measure': 'The number of patients with 2 or more scans', 'timeFrame': 'up to 5 years post-approval', 'description': 'The estimate of patients receiving multiple MRI scans will include all patients regardless if the patient has experienced a VF episode.'}, {'measure': 'Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink', 'timeFrame': 'up to 5 years post-approval', 'description': 'Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink will be summarized for MR CRT-D patients. Summary statistics will be presented separately for pre-MRI and post-MRI PCT measurements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tachyarrhythmia']}, 'descriptionModule': {'briefSummary': 'Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.', 'detailedDescription': 'Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.'}, 'identificationModule': {'nctId': 'NCT02849769', 'briefTitle': 'Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic'}, 'officialTitle': 'Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study', 'orgStudyIdInfo': {'id': 'MR Tachy PAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients implanted with an MR-conditional Tachy device system', 'description': 'Patients implanted with an MR-conditional Tachy device system in the routine care', 'interventionNames': ['Device: Implant of an MR-conditional Tachy device system']}], 'interventions': [{'name': 'Implant of an MR-conditional Tachy device system', 'type': 'DEVICE', 'armGroupLabels': ['Patients implanted with an MR-conditional Tachy device system']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Product Surveillance Registry Medtronic Product Surveillance Registry', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}