Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02041702
Status:
COMPLETED
Last Update Posted:
2019-08-21
First Post:
2013-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Accent Cardiac MRI Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lyim@sjm.com', 'phone': '0085229967605', 'title': 'Clinical Project Leader Asia', 'organization': 'Abbott (formerly St. Jude Medical)'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Death, Adverse Device Effect (ADE) and Serious Adverse Device Effect (SADE) from Baseline to 1 month post MRI Scan Visit were collected.', 'description': '1. In the Serious Adverse Event Section, only SADE are reported.\n2. In the Other (Not Including Serious) Adverse Events Section, only ADE are reported.\n3. In the All-Cause Mortality Section, there are 4 deaths reported. All of them happened prior to cardiac MRI scan and were not related to study procedures.', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan', 'otherNumAtRisk': 140, 'deathsNumAtRisk': 140, 'otherNumAffected': 1, 'seriousNumAtRisk': 140, 'deathsNumAffected': 4, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 1, 'seriousNumAtRisk': 143, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'New Onset Paroxysmal Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retracted Right Atrial Lead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute Non-St Elevation Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylaxis, Anaphylactoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Dressler's Syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug Allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Righ Atrial Lead Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Ventricular Lead Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'System Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia Requiring Emergent Direct Current Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Freedom From MRI Scan-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '100', 'ciLowerLimit': '97.6', 'ciUpperLimit': '100', 'estimateComment': 'The null hypothesis would be rejected if the lower bound of the 2-sided 90% confidence interval was greater than 90%.', 'groupDescription': 'The hypothesis was: H0: P≤ 90% vs H1: P\\>90% P: The proportion of subjects free from MRI scan related complications at 1 month post MRI scan in cardiac MRI scan group', 'statisticalMethod': 'Clopper-Pearson', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Clopper-Pearson CI for the binomial proportion', 'nonInferiorityComment': 'The 2-sided 90% confidence interval (CI) was calculated using the Clopper-Pearson method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MRI Visit ,1 Month Post MRI Visit', 'description': 'Number of subjects who were free from MRI scan-related complications', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects in Cardiac MRI Scan group who underwent an elective non-diagnostic cardiac MRI scan and completed all protocol specific visits were included in the analysis. Subjects who withdrew from the study before 1 month post MRI visit and had no MRI scan related complications were excluded.'}, {'type': 'PRIMARY', 'title': 'Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '3.8', 'estimateComment': 'The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.', 'groupDescription': 'The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL\\>-10%\n\n* PMRI: the success rate in the Cardiac MRI scan group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit\n* PCTRL: the success rate in the Control group for the change in right atrial capture threshold @0.5ms at 1month post MRI compared to pre-MRI scan value collected at MRI scan visit', 'statisticalMethod': 'Farrington-Manning Test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MRI Visit ,1 Month Post MRI Visit', 'description': 'Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \\&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use'}, {'type': 'PRIMARY', 'title': 'Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.7', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '2.8', 'estimateComment': 'The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.', 'groupDescription': 'The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \\>-10%\n\n* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit\n* PCTRL: the success rate in Control Group for change in RV capture threshold value @0.5ms at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \\&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use'}, {'type': 'PRIMARY', 'title': 'Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0446', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.7', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '4.3', 'estimateComment': 'The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.', 'groupDescription': 'The hypothesis was:H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \\>-10%\n\n* PMRI: the success rate in MRI Scan Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit\n* PCTRL: the success rate in Control Group for change in RA sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \\&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use'}, {'type': 'PRIMARY', 'title': 'Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}], 'classes': [{'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '8.4', 'estimateComment': 'The null hypothesis would be rejected if the lower bound of the two-sided 90% confidence interval was greater than -10%.', 'groupDescription': 'The hypothesis was: H0: PMRI - PCTRL≤ -10% vs H1: PMRI - PCTRL \\>-10%\n\n* PMRI: the success rate in the Cardiac MRI Scan Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit\n* PCTRL: the success rate in the Control Group for change in RV sensing amplitude at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit', 'statisticalMethod': 'Farrington-Manning test', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The 2-sided 90% CI for difference in success rate between 2 groups was calculated by Farrington-Manning method.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV \\&1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrollment \\& Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'Pre MRI Scan/ Pre Waitng', 'comment': 'Control Group: No non diagnostic cardiac MRI scan, subjects waited for 45 minutes +/- 15 minutes', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'Post MRI Scan/ Post Waiting', 'comment': 'Control Group: No non diagnostic cardiac MRI scan, subjects waited for 45 minutes +/- 15 minutes', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'comment': 'One month post MRI Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '134'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Patient not confirmed as MRI compatible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Cardiac Resynchronization Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac MRI Scan Group', 'description': 'Non-diagnostic cardiac MRI scan'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'No non-diagnostic cardiac MRI scan'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '67.4', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiomyopathy History', 'classes': [{'title': 'Ischemic Cardiomyopathy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Non-ischemic Cardiomyopathy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Arrhythmia History', 'classes': [{'title': 'Atrial Fibrillation', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Atrial Flutter', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Premature Ventricular', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Monomorphic Ventricular Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Supraventricular Tachycardia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiovascular Medication', 'classes': [{'title': 'Angiotensin Converting Enzyme Inhibitor', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Angiotensin II Receptor Blockers', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Beta-Blockers', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Aldosterone Inhibitors', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Antiarrhythmics (Class I)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Antiarrhythmics (Class II)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Anticoagulants', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Antiplatelets', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Calcium Channel Blockers', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Cardiac Glycosides (Digitalis)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Diuretics', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Nitrates', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Other Medication', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 283}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2013-12-20', 'resultsFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-06', 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom From MRI Scan-related Complications', 'timeFrame': 'MRI Visit ,1 Month Post MRI Visit', 'description': 'Number of subjects who were free from MRI scan-related complications'}, {'measure': 'Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan', 'timeFrame': 'MRI Visit ,1 Month Post MRI Visit', 'description': 'Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit'}, {'measure': 'Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit'}, {'measure': 'Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit'}, {'measure': 'Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan', 'timeFrame': 'MRI Visit, 1 Month Post MRI Visit', 'description': 'Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Bradycardia', 'MRI Conditional Pacemaker', 'St Jude Medical', 'Accent MRI Pacemaker', 'Tendril MRI Lead'], 'conditions': ['Bradycardia']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess safety and efficacy of SJM MRI conditional pacing system. The study hypothesized that cardiac MRI scan would not affect performance of SJM MRI conditional pacing system.', 'detailedDescription': 'Accent Cardiac MRI study was a prospective, randomized ,multi-center study conducted in Asia. Subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either Cardiac MRI Scan Group or Control Group.\n\nClinical evaluation and device interrogation were performed at baseline, pre- and post-MRI scan, and one month post-MRI for all subjects. At 9-12 weeks post-implant, patients in Cardiac MRI Scan Group underwent an elective non-diagnostic cardiac MRI scan at 1.5 Tesla (T) while patients in Control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. The safety endpoint was freedom from MRI-related complications while efficacy endpoint was change in right atrial/ ventricular (RA/RV) capture threshold and sensing amplitude from pre-MRI scan to one month post-MRI scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Have an approved indication per American College of Cardiology(ACC)/ American Heart Association(AHA)/ Heart Rhythm Society(HRS)/ European Society of Cardiology(ESC) guidelines for implantation of a pacemaker\n* Will receive a new dual chamber pacemaker and leads\n* Be willing to undergo an elective MRI scan without complete sedation, that is ,under consciousness during MRI scan\n* Be able to provide informed consent for study participation\n* Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations\n* Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)\n* Age≥18 years\n* Subjects must be able to undergo pectoral implantation\n\nExclusion Criteria\n\n* Having an existing pacemaker or Implantable Cardioverter Defibrillator (ICD) .A new pacemaker and lead is required for enrollment\n* Permanent Atrial Fibrillation/Flutter\n* Are medically indicated for an MRI scan at the time of enrollment\n* Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc\n* Have a non-MRI compatible device or material implanted\n* Have a lead extender or adaptor\n* Be unable to fit in MRI bore; will come into contact with the magnet façade inside the MRI bore\n* Are currently participating in a clinical investigation that includes an active treatment arm\n* Are allergic to dexamethasone sodium phosphate(DSP)\n* Are pregnant or planning to become pregnant during the duration of the study\n* Have a life expectancy of less than 12 months due to any condition\n* Subjects with exclusion criteria required by local law (e.g. age)\n* Are unable to comply with the follow up schedule'}, 'identificationModule': {'nctId': 'NCT02041702', 'acronym': 'Accent Cardiac', 'briefTitle': 'Accent Cardiac MRI Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Clinical Evaluation of the Safety and Efficacy of St. Jude Medical (SJM) Magnetic Resonance Imaging (MRI) Conditional Pacing System in Patients Undergoing Cardiac MRI', 'orgStudyIdInfo': {'id': 'CR-13-031-AP-LV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac MRI Scan Group', 'interventionNames': ['Diagnostic Test: Non-Diagnostic Cardiac MRI scan']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Non-Diagnostic Cardiac MRI scan', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Cardiac MRI Scan Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': 'Zhejiang Greentown Cardiovascular Disease Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Mohali', 'state': 'Punjab', 'country': 'India', 'facility': 'Fortis Hospital', 'geoPoint': {'lat': 30.67995, 'lon': 76.72211}}, {'city': 'Ahmedabad', 'country': 'India', 'facility': 'Care Institute of Medical Sciences', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bhubaneshwar', 'country': 'India', 'facility': 'Apollo Hospitals, Bhubaneshwar'}, {'city': 'Gurgaon', 'country': 'India', 'facility': 'Medanta - The Medicity Hospital', 'geoPoint': {'lat': 25.49781, 'lon': 82.15916}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'All India Institute of Medical Sciences, New Delhi', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Fortis Escorts Heart Institute and Research Center', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'New Delhi', 'country': 'India', 'facility': 'Fortis Flt. Lt. Rajan Dhall Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'city': 'Kajang', 'country': 'Malaysia', 'facility': 'Serdang Hospital', 'geoPoint': {'lat': 2.99424, 'lon': 101.78875}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chi Keong Ching, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart Center Singapore'}, {'name': 'Rabindra Nath Chakraborty, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Apollo Gleneagles Hospital Kolkata India'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}