Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-28 @ 5:47 AM
Study NCT ID:
NCT02636712
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observation of ImageReady™ MR Conditional Pacing System in China
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054537', 'term': 'Atrioventricular Block'}, {'id': 'D019462', 'term': 'Syncope, Vasovagal'}], 'ancestors': [{'id': 'D006327', 'term': 'Heart Block'}, {'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'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'suyangang111@163.com', 'phone': '+86 13788905096', 'title': 'Dr Yangang Su', 'organization': 'Zhongshan Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Pre-Discharge, MR Scan Visit, MRI Visit+1 Week, MRI Visit+1 Month', 'eventGroups': [{'id': 'EG000', 'title': 'ImageReady™ MR Conditional Pacing System', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Without Complications at MRI Visit + 1 Month.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ImageReady™ MR System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after the Pacemaker been implanted.', 'description': 'No one has any complications related MR Scan . So Complication-Free rate is 100%.', 'unitOfMeasure': 'percentage of paticipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%.', 'unitOfMeasure': 'percentage of paticipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%.', 'unitOfMeasure': 'percentage of paticipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without System-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 3 months after the Pacemaker been implanted.', 'description': 'No one has any complications related system occurred. So Complication-Free rate is 100%.', 'unitOfMeasure': 'percentage of paticipants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The recruitment has finished on 25 Dec 2015 and totally 10 patients.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ImageReady™ System Indication', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines\n\nImageReady™ MR Conditional Pacing System'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.4', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Year', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2015-12-11', 'resultsFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2015-12-17', 'lastUpdatePostDateStruct': {'date': '2020-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-15', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Without Complications at MRI Visit + 1 Month.', 'timeFrame': 'Within 1 month after the Pacemaker been implanted.', 'description': 'No one has any complications related MR Scan . So Complication-Free rate is 100%.'}, {'measure': 'Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent.'}, {'measure': 'Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%.'}, {'measure': 'Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan.', 'timeFrame': 'Pre-MR scan and 1 Month post-MR Scan.', 'description': 'The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Without System-related Complications', 'timeFrame': 'Within 3 months after the Pacemaker been implanted.', 'description': 'No one has any complications related system occurred. So Complication-Free rate is 100%.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arhythmia', 'Atrioventricular Heart-block', 'Chronic Bundle Branch or Branch Block', 'Carotid Sinus Hypersensitivity Reaction Syndrome', 'Vasovagal Syncope']}, 'referencesModule': {'references': [{'pmid': '21969340', 'type': 'BACKGROUND', 'citation': 'Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.'}, {'pmid': '23453091', 'type': 'BACKGROUND', 'citation': 'Russo RJ. Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Am Heart J. 2013 Mar;165(3):266-72. doi: 10.1016/j.ahj.2012.12.004. Epub 2013 Jan 28.'}, {'type': 'BACKGROUND', 'citation': 'BSC data on file. 91022242_SAMURAI_FDA endpoint report_29JUN2015_Final_revAC.'}, {'type': 'BACKGROUND', 'citation': 'ASTM Standard F2503-08, "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment" ASTM International, West Conshohocken, PA, 2008, DOI: 10.1520/F2503-08, www.astm.org'}, {'pmid': '18547191', 'type': 'BACKGROUND', 'citation': 'Wolf SM, Lawrenz FP, Nelson CA, Kahn JP, Cho MK, Clayton EW, Fletcher JG, Georgieff MK, Hammerschmidt D, Hudson K, Illes J, Kapur V, Keane MA, Koenig BA, Leroy BS, McFarland EG, Paradise J, Parker LS, Terry SF, Van Ness B, Wilfond BS. Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics. 2008 Summer;36(2):219-48, 211. doi: 10.1111/j.1748-720X.2008.00266.x.'}, {'pmid': '17515363', 'type': 'BACKGROUND', 'citation': 'Kanal E, Barkovich AJ, Bell C, Borgstede JP, Bradley WG Jr, Froelich JW, Gilk T, Gimbel JR, Gosbee J, Kuhni-Kaminski E, Lester JW Jr, Nyenhuis J, Parag Y, Schaefer DJ, Sebek-Scoumis EA, Weinreb J, Zaremba LA, Wilcox P, Lucey L, Sass N; ACR Blue Ribbon Panel on MR Safety. ACR guidance document for safe MR practices: 2007. AJR Am J Roentgenol. 2007 Jun;188(6):1447-74. doi: 10.2214/AJR.06.1616. No abstract available.'}, {'type': 'BACKGROUND', 'citation': '张澍, 华伟, 黄德嘉, 王景峰, 吴立群, 杨杰孚, 曹克将, 黄从新, 王方正, 陈新: 植入性心脏起搏器治疗--目前认识和建议(2010年修订版). 中华心律失常学杂志 2010; 04:245-249. Shu Zhang, Wei Hua, Dejia Huang, Jingfeng Wang, Liqun Wu, Jiefu Wu, Kejiang Cao, Congxin Huang, Fangzheng Wang, Xin Chen: Implantable Cardiac Pacemaker therapy- Cognition and Suggestion Present ( updated version on 2010). Chinese Journal of Cardiac Arrhythmia, 2010; 04:245-249'}]}, 'descriptionModule': {'briefSummary': 'To observe the safety and efficacy of ImageReady™ MR Conditional Pacing System in Chinese subjects', 'detailedDescription': 'Key Inclusion Criteria:\n\n1. Subject must have the Image Ready System as their initial (de novo) pacing system implant.\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines.\n3. Subject is able and willing to undergo an MR scan.•\n4. Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at the intervals defined by this protocol.\n5. Subject is age 18 or above.\n\nKey Exclusion Criteria\n\n1. Subject has or has had any pacing or ICD system implants.\n2. Subject has any implants or devices that are not suitable for MR scan.\n3. Subject is enrolled in any other concurrent study that might interfere with this study.\n4. Subject has documented life expectancy of less than 12 months.\n5. Women of childbearing potential who are or might be pregnant at the time of this study.\n\nPrimary Safety Endpoint:\n\nMR Scan related Complication Free Rate Analyzed at MRI Visit +1 Month.\n\nPrimary efficacy Endpoint:\n\n1. Pacing Threshold (at 0.5 ms pulse width) comparison pre and 1 Month post MR Scan: pacing threshold increase ≤ 0.5 V after scan.\n2. Sensed Amplitude comparison pre- and 1 Month post-MR Scan: sensed amplitude: ≥ 1.0 mV after scan, and ≥ 50% of that before scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Subjects included in the MR China Study should be selected from the investigator's general patient population indicated for single or dual chamber pacemaker implantation.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have the ImageReady System as their initial (de novo) pacing system implant\n* Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines5\n* Subject is able and willing to undergo an MR scan\n* Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at the intervals defined by this protocol\n* Subject is age 18 or above\n\nExclusion Criteria:\n\n* Subject has or has had any pacing or ICD system implants\n* Subject has any implants or devices that are not suitable for MR scan\n* Subject is enrolled in any other concurrent study that might interfere with this study\n* Subject has documented life expectancy of less than 12 months\n* Women of childbearing potential who are or might be pregnant at the time of this study'}, 'identificationModule': {'nctId': 'NCT02636712', 'briefTitle': 'Observation of ImageReady™ MR Conditional Pacing System in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Observation of ImageReady™ MR Conditional Pacing System in China', 'orgStudyIdInfo': {'id': 'C1913'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ImageReady™ MR Conditional Pacing System', 'description': '1. Subject must have the ImageReady™ System as their initial (de novo) pacing system implant\n2. Subject has a Class I or II indication for implantation of a pacemaker according to the CSPE guidelines', 'interventionNames': ['Device: ImageReady™ MR Conditional Pacing System']}], 'interventions': [{'name': 'ImageReady™ MR Conditional Pacing System', 'type': 'DEVICE', 'armGroupLabels': ['ImageReady™ MR Conditional Pacing System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yangang Su, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Zhongshan Hospital'}, {'name': 'Kejiang Cao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}