Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT04074434
Status:
COMPLETED
Last Update Posted:
2019-09-03
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Watch Atrial Fibrillation (AF) Detection Investigation
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)', 'timeFrame': 'At least 60 minutes', 'description': 'Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm'}, {'measure': 'PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data.', 'timeFrame': '14 days', 'description': 'Number of AF events identified from FDA-cleared ECG Device'}], 'secondaryOutcomes': [{'measure': 'Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF)', 'timeFrame': 'At least 60 minutes', 'description': 'Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm'}, {'measure': 'Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population.', 'timeFrame': '14 days', 'description': 'Qualitative listing of participant-reported feedback'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with a known history of AF (including persistent or paroxysmal AF)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Able to read and speak English\n* Able and willing to sign written Informed Consent\n* Interest in participating in the study\n* Subjects with a known history of AF (including persistent or paroxysmal AF)\n* Without significant limitation in ability to participate in the study, in the opinion of the investigator.\n\nExclusion Criteria:\n\n* Currently in a paced rhythm\n* Known severe allergy to nickel or metal jewelry\n* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies'}, 'identificationModule': {'nctId': 'NCT04074434', 'briefTitle': 'Study Watch Atrial Fibrillation (AF) Detection Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Verily Life Sciences LLC'}, 'officialTitle': 'Study Watch Atrial Fibrillation (AF) Detection Investigation', 'orgStudyIdInfo': {'id': '100145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Participants', 'interventionNames': ['Device: Study Watch']}], 'interventions': [{'name': 'Study Watch', 'type': 'DEVICE', 'description': 'Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data', 'armGroupLabels': ['All Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cardiac Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Verily Life Sciences LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}