Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-25 @ 12:54 PM
Study NCT ID:
NCT02977104
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maestro Handheld Cardiac Monitor Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-27', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of atrial fibrillation detection', 'timeFrame': '6 seconds', 'description': 'Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the Maestro hand held heart monitor can accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.', 'detailedDescription': "The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias, specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared to the ECG results to assess Maestro's accuracy.\n\nData will be analyzed by a pass/fail criterial. The data will be downloaded and printed for the investigators' interpretation who will first review and code the data from Meastro, blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2 sets of data will be compared. The ECG result is the true value with which to compare the Maestro result."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* implanted pacemakers\n* open wounds or abrasions on their hands\n* prior damage to hands or thumbs precluding obtaining an ECG tracing'}, 'identificationModule': {'nctId': 'NCT02977104', 'briefTitle': 'Maestro Handheld Cardiac Monitor Validation', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Maestro Handheld Cardiac Monitor Validation', 'orgStudyIdInfo': {'id': 'HUM00074138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients in afib or flutter', 'description': 'Maestro ECG', 'interventionNames': ['Other: Maestro ECG']}, {'type': 'OTHER', 'label': 'Patients in sinus rhythm', 'description': 'Maestro ECG', 'interventionNames': ['Other: Maestro ECG']}], 'interventions': [{'name': 'Maestro ECG', 'type': 'OTHER', 'description': 'Telemetry is obtained through the Maestro handheld ECG device.', 'armGroupLabels': ['Patients in afib or flutter', 'Patients in sinus rhythm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Cardiovascular Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Rakesh Latchamsetty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rakesh Latchamsetty', 'investigatorAffiliation': 'University of Michigan'}}}}