Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2026-03-27 @ 11:23 PM
Study NCT ID:
NCT00979303
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2009-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'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': 'cymiyake@bcm.edu', 'phone': '832-826-5650', 'title': 'Christina Miyake', 'organization': "Children's Hospital Boston"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Adverse events were evaluated in all patients during the study, prior to discharge and in follow up at 1 month and 1 year after the procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 8, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.\n\nIntracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 6, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hematoma', 'notes': 'Groin hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'bronchospasm', 'notes': 'Brochospasm after adenosine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal syncope', 'notes': 'Vasovagal syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy', 'notes': 'Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical trauma to pathway', 'notes': 'Trauma to pathway', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin Pain', 'notes': 'Groin pain 1 week after discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'notes': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only'}, {'id': 'OG001', 'title': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.\n\nIntracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '74.4'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '52.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During the Ablation procedure', 'description': 'Total fluoroscopy time in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Radiation Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only'}, {'id': 'OG001', 'title': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.\n\nIntracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '387', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '2701'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3026'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During Ablation Procedure', 'description': 'Total radiation exposure measured in mGy', 'unitOfMeasure': 'mGy', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only'}, {'id': 'FG001', 'title': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.\n\nIntracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only'}, {'id': 'BG001', 'title': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.\n\nIntracardiac echocardiography and 3D navigational system: Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'groupId': 'BG000', 'lowerLimit': '8.0', 'upperLimit': '20.5'}, {'value': '14.7', 'groupId': 'BG001', 'lowerLimit': '8.6', 'upperLimit': '22.3'}, {'value': '14.5', 'groupId': 'BG002', 'lowerLimit': '8.0', 'upperLimit': '22.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'groupId': 'BG000', 'lowerLimit': '27.4', 'upperLimit': '92.2'}, {'value': '59.1', 'groupId': 'BG001', 'lowerLimit': '26.8', 'upperLimit': '104.0'}, {'value': '58.5', 'groupId': 'BG002', 'lowerLimit': '26.8', 'upperLimit': '104.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000', 'lowerLimit': '126', 'upperLimit': '190'}, {'value': '162.2', 'groupId': 'BG001', 'lowerLimit': '134', 'upperLimit': '184'}, {'value': '162.1', 'groupId': 'BG002', 'lowerLimit': '126', 'upperLimit': '190'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Chest circumference', 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'BG000', 'lowerLimit': '12.5', 'upperLimit': '24.5'}, {'value': '17.5', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '27'}, {'value': '17.4', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '27'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'BSA', 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'BG001', 'lowerLimit': '1.0', 'upperLimit': '2.2'}, {'value': '1.6', 'groupId': 'BG002', 'lowerLimit': '1.0', 'upperLimit': '2.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'BG000', 'lowerLimit': '15.0', 'upperLimit': '31.3'}, {'value': '22.3', 'groupId': 'BG001', 'lowerLimit': '14.9', 'upperLimit': '41.7'}, {'value': '21.9', 'groupId': 'BG002', 'lowerLimit': '14.9', 'upperLimit': '41.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intent to treat use of non fluoroscopic mapping system with traditional fluoroscopic mapping system during elective catheter ablation in children 8-17 with normal cardiac anatomy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2010-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2009-09-17', 'resultsFirstSubmitDate': '2017-11-10', 'studyFirstSubmitQcDate': '2009-09-17', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-08', 'studyFirstPostDateStruct': {'date': '2009-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Fluoroscopy Time', 'timeFrame': 'During the Ablation procedure', 'description': 'Total fluoroscopy time in minutes'}], 'secondaryOutcomes': [{'measure': 'Total Radiation Exposure', 'timeFrame': 'During Ablation Procedure', 'description': 'Total radiation exposure measured in mGy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pediatric', 'Electrophysiology', 'Ablation', 'Radiation', 'Devices', 'SVT'], 'conditions': ['Supraventricular Tachycardia']}, 'referencesModule': {'availIpds': [{'url': 'http://www.childrenshospital.org/', 'type': 'Archived consent, protocol and analytic plan.', 'comment': "Study completed prior to change in common rule. Requests should be directed to the investigation team at Boston Children's Hospital through mark.alexander@cardio.chboston.org"}], 'references': [{'pmid': '21167315', 'type': 'RESULT', 'citation': 'Miyake CY, Mah DY, Atallah J, Oikle HP, Melgar ML, Alexander ME, Berul CI, Cecchin F, Walsh EP, Triedman JK. Nonfluoroscopic imaging systems reduce radiation exposure in children undergoing ablation of supraventricular tachycardia. Heart Rhythm. 2011 Apr;8(4):519-25. doi: 10.1016/j.hrthm.2010.12.022. Epub 2010 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the additional use of non-fluoroscopic imaging modalities can decrease the use of radiation exposure during standard ablation procedures for supraventricular tachycardia (SVT) in children.', 'detailedDescription': 'The standard of care for children undergoing SVT ablation is radiation (fluoroscopy) to see the heart. Non fluoroscopic imaging tools have been utilized for adult atrial fibrillation procedures. These tools utilize magnetic fields to visualize the heart without using radiation. The purpose of this study was to determine if these 3D mapping tools could reduce radiation exposure during SVT ablation procedures could be performed using these 3D tools.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>/=8\n* Weight \\>/=25kg\n* Structurally normal heart (no major cardiac defects)\n* History of SVT\n* No prior history of cardiac surgery or ablation\n\nExclusion Criteria:\n\n* Congenital Heart Disease\n* Prior history of cardiac surgery or ablation'}, 'identificationModule': {'nctId': 'NCT00979303', 'briefTitle': 'Using Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Adjunct Use of Non-Fluoroscopic Imaging Devices to Decrease Radiation Exposure During Ablation of Supraventricular Tachycardia', 'orgStudyIdInfo': {'id': '08110505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control Patients - Undergo ablation procedures with radiation/fluoroscopy only'}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Study Group Patients - Undergo ablation procedures using intracardiac echocardiography and 3D navigational system in addition to radiation.', 'interventionNames': ['Device: Intracardiac echocardiography and 3D navigational system']}], 'interventions': [{'name': 'Intracardiac echocardiography and 3D navigational system', 'type': 'DEVICE', 'otherNames': ['AcuNav Intracardiac Echocardiography', 'NavX 3D navigational system', 'CARTO 3D navigational system'], 'description': 'Patients assigned to the intervention group will receive both intracardiac echocardiography as well as a 3D navigational system in addition to fluoroscopy during their ablation procedure.', 'armGroupLabels': ['Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Christina Y. Miyake, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Christina Yumi Miyake', 'investigatorAffiliation': "Boston Children's Hospital"}}}}