Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-25 @ 4:47 PM
Study NCT ID:
NCT04512703
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mosz@zoll.com', 'phone': '4129683333', 'title': 'Mike Osz', 'phoneExt': '14104', 'organization': 'ZOLL Medical Corporation'}, 'certainAgreement': {'otherDetails': 'Any proposed publication relating to the research conducted under this protocol will be submitted to the sponsor for review at least 45 days prior to submission for publication. The publication may be delayed for an additional period of up to 90 days for intellectual property considerations or until all confidential information has been eliminated from the publication(s) and sponsor has approved the publication. It may be determined by the sponsor that no data from this study will be published.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days.', 'description': 'Adverse evenst were defined in the study as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects, users, or other persons whether or not related to the study device.\n\nSerious adverse events were defined per study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Group', 'description': 'Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arrhythmia Monitoring Group', 'description': 'Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 42, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Logistics of Study Device Setup and Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'title': 'Devices Assessed for Setup during Period 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Devices Assessed for Monitoring during Period 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Devices assessed for Monitoring during Period 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup', 'unitOfMeasure': 'count of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All devices in both Healthy and Arrythmia Monitoring Group were assessed for setup at the beginning of Period 1. Monitoring assessment was assessed during both Period 1 and Period 2. There was a total of 51 side position devices and 51 front position devices.'}, {'type': 'PRIMARY', 'title': 'Device Wear Time and Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '29', 'groupId': 'OG000'}, {'value': '54', 'spread': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Devices on subjects in the arrythmia group that were allocated for 90 day wear were used in the assessment.'}, {'type': 'PRIMARY', 'title': "Subject's Ability to Accurately Place Device", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'percentage of correct placements', 'reportingStatus': 'POSTED', 'populationDescription': 'A position assessment and orientation placement was assessed for accuracy for all front and side devices.'}, {'type': 'PRIMARY', 'title': 'Device Data Transmission and Device Connectivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'title': 'Devices Worn during Phase 1', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Devices Worn during Phase 2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Period 1 and Period 2', 'description': 'Count of subjects that had daily data transmission.', 'unitOfMeasure': 'count of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ability to Provide Timely Arrythmia Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position indicated for 90 day monitoring'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position indicated for long term monitoring'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '42.8', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '55.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Documentation of Clinically Actionable Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'documented clinical events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid.', 'unitOfMeasure': 'units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes both healthy and arrhythmia monitoring groups'}, {'type': 'SECONDARY', 'title': 'Association of Device Recordings to Clinical Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects', 'description': 'ECG arrythmia recordings were assessed for associations with documented symptoms in cases of arrhythmia reported symptoms'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'Arrhythmias associated with symptoms', 'reportingStatus': 'POSTED', 'populationDescription': 'Devices in all subjects were assessed for arrythmia/symptom associations. The healthy and arrhthmia monitoring groups were combined for this outcome measure as the study investigated whether documented symptoms were associated with ECG arrhythmia regardless of group allocation.'}, {'type': 'SECONDARY', 'title': 'Device Recording Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '.47', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2.', 'unitOfMeasure': 'Percent Coefficient of Variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes both healthy and arrhythmia monitoring groups'}, {'type': 'SECONDARY', 'title': 'Respiration Rate Front and Side Device Measurement Equivalency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '4.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously.', 'unitOfMeasure': 'respirations per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes both healthy and arrhythmia monitoring groups'}, {'type': 'SECONDARY', 'title': 'Activity Front and Side Device Measurement Equivalency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '981', 'spread': '934', 'groupId': 'OG000'}, {'value': '1007', 'spread': '989', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Activity counts were compared between front and side devices.', 'unitOfMeasure': 'activity counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes both healthy and arrhythmia monitoring groups'}, {'type': 'SECONDARY', 'title': 'Sleep Angle Front and Side Device Measurement Equivalency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Front Position Devices', 'description': 'Devices placed in the front position'}, {'id': 'OG001', 'title': 'Side Position Devices', 'description': 'Devices placed in the side position'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '12.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Sleep angle was compared between front and side devices.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes both healthy and arrhythmia monitoring groups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Group', 'description': 'Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers'}, {'id': 'FG001', 'title': 'Arrhythmia Monitoring Group', 'description': 'Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers'}], 'periods': [{'title': 'Within 7 Days From Start of Device Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Wore Front Position', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Wore Side Position', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Between 7th and 90th Day of Device Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Wore Side Position Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Wore Front Position Device', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'An additional subject was enrolled beyond the protocol in the arrhythmia group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Group', 'description': 'Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers'}, {'id': 'BG001', 'title': 'Arrhythmia Monitoring Group', 'description': 'Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.\n\nµCor: Sensor Monitor for arrhythmia and other bio-metric markers'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '56'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '79'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 623043, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-06T10:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2020-07-31', 'resultsFirstSubmitDate': '2020-11-18', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-02', 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Logistics of Study Device Setup and Monitoring', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup'}, {'measure': 'Device Wear Time and Compliance', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}, {'measure': "Subject's Ability to Accurately Place Device", 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}, {'measure': 'Device Data Transmission and Device Connectivity', 'timeFrame': 'Period 1 and Period 2', 'description': 'Count of subjects that had daily data transmission.'}, {'measure': 'Ability to Provide Timely Arrythmia Monitoring', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}, {'measure': 'Documentation of Clinically Actionable Events.', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}], 'secondaryOutcomes': [{'measure': 'Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid.'}, {'measure': 'Association of Device Recordings to Clinical Events', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}, {'measure': 'Device Recording Stability', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90', 'description': 'Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2.'}, {'measure': 'Respiration Rate Front and Side Device Measurement Equivalency', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously.'}, {'measure': 'Activity Front and Side Device Measurement Equivalency', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Activity counts were compared between front and side devices.'}, {'measure': 'Sleep Angle Front and Side Device Measurement Equivalency', 'timeFrame': 'Period 1: Start of device wear at Day 0 to Day 7', 'description': 'Sleep angle was compared between front and side devices.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Arrhythmia']}, 'descriptionModule': {'briefSummary': 'Prospective, non-interventional, feasibility study. 8 months, from start of screening to finishing the study. Multi-center study, with a maximum of 8 centers in Europe. Health adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.\n\nTo observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System (µCor system ) that non-invasively captures thoracic fluid content, electrocardiogram, heart rate, respiratory rate, activity, and body posture. tory outpatient cardiac monitoring.', 'detailedDescription': 'The study will consist of two phases. Phase I of the study will enroll 6 healthy volunteers, who have no indication for remote cardiac monitoring. Subjects are required to participate in the study for 30 days.\n\nPhase II of the study will enroll up to 44 patients indicated for outpatient cardiac monitoring and will participate in the study for up to 90 days.\n\nAll subjects will wear the device in two locations, one along the left midaxillary line and the other along the left midclavicular line for the first seven days.\n\nThereafter, for the remainder of the study, half the enrolled subjects will only wear the device in the left midclavicular position and the other half will wear the device in the left midaxillary position. Subjects will use a diary to keep a daily log their activities of daily living (phase I) or a log of any symptoms related to heart rhythm abnormalities and heart failure (phase II).\n\nData will be acquired with the µCor system and wirelessly transmitted daily to a remote server for processing, generating thoracic fluid content, ECG, heart rate, respiration rate, activity, and posture measurements. Investigators will have access only to ECG data.\n\nStudy staff will make weekly phone calls to subjects and record any new clinically actionable events. Patients will have monthly office visits. At the end of 30 days (phase I) or 90 days (phase II), patients will end wear and will complete the study follow-up questionnaire.\n\nThe study will enroll a maximum of 50 subjects. Six healthy volunteers will be enrolled for phase I of the study. Remaining 44 subjects will be enrolled for phase II and will have an indication of outpatient cardiac monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.', 'healthyVolunteers': True, 'eligibilityCriteria': '-Inclusion Criteria\n\nThe following criteria will be used to include subjects in phase I portion of the study:\n\n* Healthy male and female volunteers.\n* Subjects older than 21 years of age.\n* Subjects willing to wear the µCor device for up to 30 days.\n* Subjects willing to answer weekly phone calls from the study staff.\n\nThe following criteria will be used to include subjects in phase II portion of the study:\n\n* Patients with a clinical indication for outpatient cardiac monitoring.\n* Patients older than 21 years of age.\n* Patients willing to wear the µCor device for up to 90 days.\n* Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study period.\n* Patients willing to answer weekly phone calls regarding their health status.\n* Exclusion Criteria:\n\nThe following criteria will be used to exclude subjects from phases I and II portions of the study:\n\n* Subjects reporting or planning to be pregnant.\n* Subjects with any cardiac implantable electronic devices, including loop recorders.\n* Subjects with a wearable cardioverter defibrillator.\n* Subjects with Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices.\n* Subjects with any skin condition that would prevent them from wearing the µCor system.\n* Subjects who are non-ambulatory.\n* Subjects without adequate cellular transmission access that would prevent data download from the µCor device.\n* Subjects participating in another clinical study.\n* Subjects unable to give informed consent.\n* Employees of ZOLL or their family members.\n* Subjects traveling during the study participation period that prevents planned office visits and weekly phone calls from the study coordinator.\n* Subjects expected to undergo a planned MRI exam during the participation period.'}, 'identificationModule': {'nctId': 'NCT04512703', 'acronym': 'PATCH', 'briefTitle': 'Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System (PATCH) Feasibility Study', 'orgStudyIdInfo': {'id': '90D0167'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Group', 'description': 'Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.', 'interventionNames': ['Device: µCor']}, {'label': 'Arrhythmia Monitoring Group', 'description': 'Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.', 'interventionNames': ['Device: µCor']}, {'label': 'Front Position Devices', 'description': 'All devices placed in the front position'}, {'label': 'Side Position Devices', 'description': 'All devices placed in the side position'}], 'interventions': [{'name': 'µCor', 'type': 'DEVICE', 'description': 'Sensor Monitor for arrhythmia and other bio-metric markers', 'armGroupLabels': ['Arrhythmia Monitoring Group', 'Healthy Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Mike Osz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zoll Medical Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}