Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-03 @ 8:37 PM
Study NCT ID:
NCT03309956
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2017-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Holter Versus Zio Patch Electrocardiographic Monitoring in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006327', 'term': 'Heart Block'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015716', 'term': 'Electrocardiography, Ambulatory'}], 'ancestors': [{'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'll202@cumc.columbia.edu', 'phone': '212-305-8509', 'title': 'Leonardo Liberman, MD', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 hours', 'description': '247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition. Adverse Events were monitored and reported for the final 200 participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Holter Monitor and Zio Patch', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.", 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 0, 'seriousNumAtRisk': 200, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Holter Monitor and Zio Patch', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.23', 'groupIds': ['OG000'], 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': "The diagnostic yield, or the ability to detect an arrhythmia, will be measured for the Holter monitor and the Zio patch monitor for each patient. The diagnostic yield for each arrhythmia subtype will be determined for each device across all patients and compared in paired statistical analysis (McNemar's test).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition.'}, {'type': 'SECONDARY', 'title': 'Prevalence of Artifact Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Holter Monitor', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours."}, {'id': 'OG001', 'title': 'Zio Patch', 'description': 'All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '15.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '8.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.', 'unitOfMeasure': 'percentage of artifact detected', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Patients Who Preferred the Zio Over the Holter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Holter Monitor and Zio Patch', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'description': 'Descriptive statistics will be used to analyze survey results. A one page patient satisfaction survey will be filled out at the end of the 48 hours to compare patient/parental preference and possible adverse reactions for each device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Holter Monitor and Zio Patch', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '247'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Devices worn for <24 hrs or >72 hrs, device failing to record, or devices were lost', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Holter Monitor and Zio Patch', 'description': "All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.\n\nHolter Monitor: A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.\n\nZio Patch: The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.\n\n247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition. The Baseline Population characteristics are reported for the final 200 participants."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0-7 years old', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': '8-17 years old', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}]}]}, {'title': '18-65 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '>65 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '200', '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': '0', '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': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '247 subjects were enrolled. 47 patients were excluded from the arrhythmia analysis due to one or both devices being worn for \\<24 hours (n = 18) or \\>72 hours (n = 4), either device failing to record (n = 11), or one or both devices being lost (n = 14). A total of 200 patients completed the study and were included for the arrhythmia analysis after attrition. The Baseline Population characteristics are reported for the final 200 participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-26', 'size': 262851, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-20T17:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive the same intervention, namely both devices at the same time for 48 hours.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 247}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2017-10-05', 'resultsFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-22', 'studyFirstPostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Patients Who Preferred the Zio Over the Holter', 'timeFrame': '48 hours', 'description': 'Descriptive statistics will be used to analyze survey results. A one page patient satisfaction survey will be filled out at the end of the 48 hours to compare patient/parental preference and possible adverse reactions for each device.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter', 'timeFrame': '48 hours', 'description': "The diagnostic yield, or the ability to detect an arrhythmia, will be measured for the Holter monitor and the Zio patch monitor for each patient. The diagnostic yield for each arrhythmia subtype will be determined for each device across all patients and compared in paired statistical analysis (McNemar's test)."}], 'secondaryOutcomes': [{'measure': 'Prevalence of Artifact Detected', 'timeFrame': '48 hours', 'description': 'The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Ambulatory Electrocardiography', 'Holter Monitor', 'Zio Patch Monitor', 'Pediatrics'], 'conditions': ['Arrhythmias, Cardiac', 'Heart Block']}, 'referencesModule': {'references': [{'pmid': '24384108', 'type': 'BACKGROUND', 'citation': 'Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15.'}, {'pmid': '25591894', 'type': 'BACKGROUND', 'citation': 'Bolourchi M, Batra AS. Diagnostic yield of patch ambulatory electrocardiogram monitoring in children (from a national registry). Am J Cardiol. 2015 Mar 1;115(5):630-4. doi: 10.1016/j.amjcard.2014.12.014. Epub 2014 Dec 18.'}, {'pmid': '24976467', 'type': 'BACKGROUND', 'citation': 'Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014 May;10(3):319-22. doi: 10.2217/fca.14.24.'}, {'pmid': '24215754', 'type': 'BACKGROUND', 'citation': 'Lobodzinski SS. ECG patch monitors for assessment of cardiac rhythm abnormalities. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):224-9. doi: 10.1016/j.pcad.2013.08.006.'}, {'pmid': '23240827', 'type': 'BACKGROUND', 'citation': 'Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. doi: 10.1111/pace.12053. Epub 2012 Dec 13.'}, {'pmid': '24672611', 'type': 'BACKGROUND', 'citation': 'Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.'}, {'pmid': '25628595', 'type': 'BACKGROUND', 'citation': 'Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014.'}, {'pmid': '23672988', 'type': 'BACKGROUND', 'citation': 'Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, Xu X, Yang F, Heidenreich PA. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013 Aug 15;112(4):520-4. doi: 10.1016/j.amjcard.2013.04.017. Epub 2013 May 11.'}]}, 'descriptionModule': {'briefSummary': 'This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.', 'detailedDescription': "Patients under age 22 years at Children's Hospital of New York (CHONY) who are referred for ambulatory ECG monitoring will be consented and enrolled prospectively to have the Holter monitor and the Zio patch placed simultaneously in the pediatric cardiology clinic. Patients will be instructed to wear both devices for 48 hours. Demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ECG monitoring, prior congenital heart disease, prior cardiac surgery, and prior Holter or Zio patch use. A patient satisfaction survey will be given to the patient and parent/guardian after completion of the study to compare the comfort, interference with daily activities, adverse events (such as skin irritation or if either device fell off), and preference for each device. Holter monitors will be returned to the clinic along with the patient satisfaction survey, and the Zio patch will be mailed back to manufacturer headquarters and the report will be returned to the investigators."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.\n\nExclusion Criteria:\n\n* Any known skin allergy or sensitivity to adhesive material."}, 'identificationModule': {'nctId': 'NCT03309956', 'briefTitle': 'Holter Versus Zio Patch Electrocardiographic Monitoring in Children', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children', 'orgStudyIdInfo': {'id': 'AAAR5436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Holter Monitor and Zio Patch', 'description': 'All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.', 'interventionNames': ['Device: Holter Monitor', 'Device: Zio Patch']}], 'interventions': [{'name': 'Holter Monitor', 'type': 'DEVICE', 'description': "A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.", 'armGroupLabels': ['Holter Monitor and Zio Patch']}, {'name': 'Zio Patch', 'type': 'DEVICE', 'description': 'The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.', 'armGroupLabels': ['Holter Monitor and Zio Patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leonardo Liberman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}