Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT03477734
Status:
COMPLETED
Last Update Posted:
2020-07-21
First Post:
2018-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Males and females, 50 of them diagnosed with atrial fibrillation (AF), and 50 healthy participants, at least 30% of each gender in each group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-19', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-03-18', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CardicacSense1 atrial fibrillation detection rate', 'timeFrame': '24 to 48 hours', 'description': 'Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.'}, {'measure': 'Safety of CardicacSense1', 'timeFrame': '24 to 48 hours', 'description': 'Incidence and severity of device related Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Usability', 'timeFrame': '24 to 48 hours', 'description': 'Ease of use of the CardiacSense1 device based on user questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrium; Fibrillation']}, 'descriptionModule': {'briefSummary': 'A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.\n\nThe clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device', 'detailedDescription': 'The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:\n\n100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).\n\nAll subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference\n\nFor PPG analysis, each one hour will be considered as an event:\n\nIf A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".\n\nFor ECG analysis, each measurement of between 1-3 minutes will be considered an event.\n\nIf A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".\n\nSensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.\n\nThe asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age of eighteen (18) year and above\n* Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems\n\nExclusion Criteria:\n\n* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.\n* Subjects with low perfusion as indicated by the watch\n* Women who are pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT03477734', 'briefTitle': 'Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardiacSense Ltd.'}, 'officialTitle': 'A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CL00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CS1 & heart monitor - AF patients', 'description': 'Males and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed', 'interventionNames': ['Device: CS1 & heart monitor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CS1 & heart monitor -Healthy volunteers', 'description': 'Males and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed', 'interventionNames': ['Device: CS1 & heart monitor']}], 'interventions': [{'name': 'CS1 & heart monitor', 'type': 'DEVICE', 'description': 'Daily activities while wearing the investigational device as well as the control device', 'armGroupLabels': ['CS1 & heart monitor - AF patients', 'CS1 & heart monitor -Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '62431', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Ofer Havakuk, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardiacSense Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}