Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-05 @ 7:35 PM
Study NCT ID:
NCT02877693
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'grant.kim1@abbott.com', 'phone': '818-493-3147', 'title': 'Grant Kim, Director Clinical Programs', 'organization': 'Abbott'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The 3T MRI part of the study was not completed as the study was terminated upon completion of the 1.5T MRI part of the study'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time participants were enrolled, through the MRI scan Visit and the 1 month Post MRI Scan Visit follow-up, or the study completion (if subject withdrawn before the final follow-up).', 'description': '* Adverse Device Effect (ADE)- An adverse event (AE) related to the use of a medical device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the medical device and any event resulting from the use error or from intentional misuse of the medical device.\n* Serious Adverse Device Effect - ADE that has resulted in any of the consequences characteristic of a Serious AE', 'eventGroups': [{'id': 'EG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.', 'otherNumAtRisk': 205, 'deathsNumAtRisk': 205, 'otherNumAffected': 1, 'seriousNumAtRisk': 205, 'deathsNumAffected': 2, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Loss of Capture', 'notes': 'Device loss of capture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Breathlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Refractory cardiogenic shock, recurrent ventricular tachycardia, ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious Adverse Device Effect: Acute Pulmonary Edema', 'notes': "\\*Event was conservatively classified as SADE due to unknown relationship to the device per the investigator's assessment.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from MRI scan visit to 1 month post-MRI scan visit', 'description': '\\*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death.\n\nThe primary endpoint analysis will be performed for each study phase separately.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '177 subjects (86.3% of enrolled subjects) completed through the 1-month post-MRI scan visit and are included in the primary safety endpoint analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Average Specific Absorption Rate (SAR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MRI scan visit', 'description': 'The average Specific Absorption Rate (SAR) during the MRI scan', 'unitOfMeasure': 'Watts/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing the MRI scan in its entirety'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from MRI scan visit to 1-month post MRI scan visit', 'description': 'This proportion was calculated as the number of subjects who had high voltage leads with capture threshold increases of ≤ 0.5V @ 0.5 ms from pre MRI scan testing to 1-month post MRI scan testing divided by total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre-MRI scan and 1-month post MRI scan capture threshold measurements available.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of SJM High Voltage Lead Implanted With SJM MR Conditional ICD With Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1 Month Post-MRI Scan Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from pre MRI scan to 1-month post MRI scan', 'description': 'This proportion was calculated as the number of subjects who had high voltage leads with sensing amplitude decrease of ≤ 50% from pre MRI scan testing to 1 month post MRI scan testing divided by the total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Peak Specific Absorption Rate (SAR) During the MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MRI Scan Visit', 'description': 'The peak Specific Absorption Rate (SAR) during the MRI scan', 'unitOfMeasure': 'W/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The peak SAR was calculated for 56 subjects with available data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean MRI Visit Duration in the MRI Lab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '11.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MRI Visit', 'description': 'The mean MRI visit duration in the MRI lab', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mean MRI visit duration in the MRI lab for 181 subjects completing the MRI scan visit'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Total MRI Scan Duration in MRI Laboratory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MRI Visit', 'description': 'Total MRI scan duration in MRI laboratory', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects completing the MRI scan'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}, {'id': 'FG001', 'title': 'Thoracic MRI Scan With 3 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'comment': 'This arm was not completed. As of the data cut-off date for this clinical study report subject enrollment criteria was met for the 1st arm of the study and the sponsor decided not to move forward with 3T arm of the study.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subject enrollment in the Asia MRI ICD study began on October 10, 2016. The study enrolled 205 subjects at 20 clinical sites. Completion of enrollment and follow-up in the study occurred on March 23, 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Thoracic MRI Scan With 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '13.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '173', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '178', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '201', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cardiovascular History', 'classes': [{'categories': [{'title': 'Non-ischemic Cardiomyopathy', 'measurements': [{'value': '75', 'groupId': 'BG000'}]}, {'title': 'Ischemic Cardiomyopathy', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'No Cardiomyopathy', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Indication for ICD Implant', 'classes': [{'categories': [{'title': 'Cardiac Arrest', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Ventricular Tachycardia', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': 'Ischemic Cardiomyopathy', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Non-ischemic Cardiomyopathy', 'measurements': [{'value': '50', 'groupId': 'BG000'}]}, {'title': 'Syncope', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Familial Condition', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Smoking', 'classes': [{'categories': [{'title': 'Number of years smoking < 10', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Number of years smoking 10 - 20', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Number of years smoking > 20', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'No smoking or no response', 'measurements': [{'value': '176', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population consisted of study participants that provided and signed acknowledgement of informed consent and were enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-04', 'size': 2373214, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-28T19:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2016-08-19', 'resultsFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-01', 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Average Specific Absorption Rate (SAR)', 'timeFrame': 'MRI scan visit', 'description': 'The average Specific Absorption Rate (SAR) during the MRI scan'}, {'measure': 'Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System', 'timeFrame': 'from MRI scan visit to 1-month post MRI scan visit', 'description': 'This proportion was calculated as the number of subjects who had high voltage leads with capture threshold increases of ≤ 0.5V @ 0.5 ms from pre MRI scan testing to 1-month post MRI scan testing divided by total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre-MRI scan and 1-month post MRI scan capture threshold measurements available.'}, {'measure': 'Proportion of SJM High Voltage Lead Implanted With SJM MR Conditional ICD With Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1 Month Post-MRI Scan Testing', 'timeFrame': 'from pre MRI scan to 1-month post MRI scan', 'description': 'This proportion was calculated as the number of subjects who had high voltage leads with sensing amplitude decrease of ≤ 50% from pre MRI scan testing to 1 month post MRI scan testing divided by the total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available.'}, {'measure': 'The Peak Specific Absorption Rate (SAR) During the MRI Scan', 'timeFrame': 'MRI Scan Visit', 'description': 'The peak Specific Absorption Rate (SAR) during the MRI scan'}, {'measure': 'The Mean MRI Visit Duration in the MRI Lab', 'timeFrame': 'MRI Visit', 'description': 'The mean MRI visit duration in the MRI lab'}, {'measure': 'Total MRI Scan Duration in MRI Laboratory', 'timeFrame': 'MRI Visit', 'description': 'Total MRI scan duration in MRI laboratory'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System', 'timeFrame': 'from MRI scan visit to 1 month post-MRI scan visit', 'description': '\\*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death.\n\nThe primary endpoint analysis will be performed for each study phase separately.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICD', 'Thoracic MRI Scan', 'tachycardia'], 'conditions': ['ICD', 'Tachycardia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Tarlochan Singh Kler, Praveen Chandra, Chandrakant Chavan, Rajesh Vijayvergiya, Subhash Chandra, Anoop Gupta, Sridevi Chennapragada, Joung Bo Young, Mona Bhatia, Choi Eue Keun, Vanita Arora, Tom Devasia, Upendra Kaul, Sumit Anand, Kartikeya Bhargava. Initial experience of thoracic Magnetic Resonance Imaging (MRI) scanning in Asian patients implanted the Ellipse MR Conditional ICD System - The ASIA MRI ICD Study. APHRS 2017; Abstract no. 40528.'}]}, 'descriptionModule': {'briefSummary': 'To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.', 'detailedDescription': 'This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days\n2. Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan\n3. Subject's ventricular bipolar capture threshold is stable \\< 2.5V @ 0.5ms\n4. Subject's ventricular sensing is measurable (patient has underlying rhythm \\> 30bpm) and the sensing amplitude is stable \\> 4mV\n5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)\n6. Subject is willing and able to comply with the prescribed follow-up tests and procedures\n7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)\n\nExclusion Criteria:\n\n1. Subject is pacemaker dependent\n2. Subject has a non SJM MRI compatible endocardial lead implanted or capped\n3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.\n4. Subject has a high voltage lead revision incidence \\< 60 days of the enrollment visit\n5. Subject has other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included\n6. Subject has a lead extender, adaptor, or capped/abandoned lead\n7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.\n8. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study\n9. Subject has a life expectancy of less than 12 months due to any condition\n10. Subject has exclusion criteria required by local law (e.g., age)"}, 'identificationModule': {'nctId': 'NCT02877693', 'acronym': 'ASIA MRI ICD', 'briefTitle': 'A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'SJM-CIP-10163'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thoracic MRI Scan with 1.5 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.', 'interventionNames': ['Radiation: Thoracic MRI Scan']}, {'type': 'EXPERIMENTAL', 'label': 'Thoracic MRI Scan with 3 Tesla MRI', 'description': 'Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.', 'interventionNames': ['Radiation: Thoracic MRI Scan']}], 'interventions': [{'name': 'Thoracic MRI Scan', 'type': 'RADIATION', 'description': 'The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.', 'armGroupLabels': ['Thoracic MRI Scan with 1.5 Tesla MRI', 'Thoracic MRI Scan with 3 Tesla MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122001', 'city': 'Gurgaon', 'state': 'Haryana', 'country': 'India', 'facility': 'Medanta-The Medicity', 'geoPoint': {'lat': 28.4601, 'lon': 77.02635}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Post Graduate Institute of Medical Education & Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '110005', 'city': 'Delhi', 'country': 'India', 'facility': 'BLK Super Speciality Hospital', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110017', 'city': 'Delhi', 'country': 'India', 'facility': 'Max Super Specialty Hospital', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'zip': '110017', 'city': 'Delhi', 'country': 'India', 'facility': 'Pushpawati Singhania Research Institute', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Delhi', 'country': 'India', 'facility': 'Apollo Gleneagles Hospital', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Delhi', 'country': 'India', 'facility': 'Batra Hospital & Medical Research Centre', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}, {'city': 'Delhi', 'country': 'India', 'facility': 'Fortis Flt. Lt. 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