Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT05472012
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': 'studies@masimo.com', 'phone': '949-297-7000', 'title': 'Chelsea Frank', 'organization': 'Masimo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1-5 hours', 'eventGroups': [{'id': 'EG000', 'title': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 1, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Arm Cramp', 'notes': "The subject's arm experienced a cramp during the study, but the study continued once the cramp subsided.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'classes': [{'categories': [{'measurements': [{'value': '96.97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.', 'unitOfMeasure': '% of true positive', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis.'}, {'type': 'PRIMARY', 'title': 'Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-5 hours', 'description': 'Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.', 'unitOfMeasure': '% of true negative', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 23 subjects were excluded from the data analysis based on the protocol criteria. This included individuals whose reference or test ECG did not provide readable waveforms, as determined by medical personnel, and those who appeared to have atrial fibrillation (Afib) at enrollment but provided waveforms that were inconsistent with an Afib diagnosis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.\n\nINVSENSOR00057: Noninvasive wearable health monitoring device'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '74', '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': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-27', 'size': 8936025, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-06T16:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'dispFirstSubmitDate': '2024-01-23', 'completionDateStruct': {'date': '2023-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2022-07-21', 'resultsFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2022-07-21', 'dispFirstPostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-06', 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function', 'timeFrame': '1-5 hours', 'description': 'Afib detection accuracy will be determined by analyzing the sensitivity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.'}, {'measure': 'Specificity of INVSENSOR00057 Atrial Fibrillation (Afib) Detection Function', 'timeFrame': '1-5 hours', 'description': 'Afib detection accuracy will be determined by analyzing the specificity of INVSENSOR00057 Afib detection function when compared to data collected using a FDA-cleared ECG monitor.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18 years of age or older.\n* Subject is confirmed to have active atrial fibrillation at the time of enrollment.\n\nExclusion Criteria:\n\n* Subject is confirmed to have concurrent active arrhythmias (e.g., PVCs, bradycardia, etc.) at the time of enrollment.\n* Subject is allergic to adhesives or ECG gel.\n* Subject whose skin is not intact in or at the vicinity of the device placement site.'}, 'identificationModule': {'nctId': 'NCT05472012', 'briefTitle': 'Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Masimo Corporation'}, 'officialTitle': 'Performance of Masimo INVSENSOR00057 in Detecting Atrial Fibrillation (Afib)', 'orgStudyIdInfo': {'id': 'ROBI0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INVSENSOR00057', 'description': 'All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device.', 'interventionNames': ['Device: INVSENSOR00057']}], 'interventions': [{'name': 'INVSENSOR00057', 'type': 'DEVICE', 'description': 'Noninvasive wearable health monitoring device', 'armGroupLabels': ['INVSENSOR00057']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masimo Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}