Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT04041466
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2019-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of a Watch for the Detection of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF and SR classification accuracy', 'timeFrame': '1 visit (30 minutes)', 'description': 'sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG'}], 'secondaryOutcomes': [{'measure': 'Quality of the 1-lead ECG strips', 'timeFrame': '1 visit (30 minutes)', 'description': 'sensitivity and specificity of detection of AF and SR from 1-lead ECG strips reviewed by a blind, trained cardiologist against reference 12-lead ECG'}, {'measure': 'safety evaluation', 'timeFrame': '1 visit (30 minutes)', 'description': 'frequency of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Arrhythmias, Cardiac', 'Cardiovascular diseases', 'Heart diseases', 'Wearable Electronic Devices', 'Electrocardiography'], 'conditions': ['Atrial Fibrillation', 'Arrythmia, Cardiac']}, 'descriptionModule': {'briefSummary': 'The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults, men or women, at least 18 years old\n* person having signed the informed consent form\n* person affiliated to a social security system\n\nExclusion Criteria:\n\n* vulnerable subject according to current regulation:\n\n * pregnant woman, parturient or breastfeeding\n * subject deprived of freedom by judicial, medical or administrative decision\n * subject legally protected or unable to express his consent\n * subject non-beneficiary of healthcare\n * subject falling into more than one of the above categories\n* subject who refused to participate in the study\n* subject in linguistic or psychic incapacity to sign a written informed consent form\n* subject in physical incapacity to wear a watch on their wrist\n* subject with electrical stimulation by pacemaker'}, 'identificationModule': {'nctId': 'NCT04041466', 'acronym': 'MOVE-ECG', 'briefTitle': 'Validation Study of a Watch for the Detection of Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Withings'}, 'officialTitle': 'Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation', 'orgStudyIdInfo': {'id': '2019-A00721-56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atrial fibrillation (AF)', 'description': 'Patients diagnosed with AF during reference ECG', 'interventionNames': ['Diagnostic Test: AF detection by ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Sinus Rhythm (SR)', 'description': 'Patients diagnosed with SR during reference ECG', 'interventionNames': ['Diagnostic Test: AF detection by ECG']}, {'type': 'EXPERIMENTAL', 'label': 'Other Arrythmia', 'description': 'Patients diagnosed with an arrhythmia other than AF during the reference ECG', 'interventionNames': ['Diagnostic Test: AF detection by ECG']}], 'interventions': [{'name': 'AF detection by ECG', 'type': 'DIAGNOSTIC_TEST', 'description': 'Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG', 'armGroupLabels': ['Atrial fibrillation (AF)', 'Other Arrythmia', 'Sinus Rhythm (SR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13090', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique AXIUM Centre de cardiologie', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'Centre Cardiologique du Nord', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Withings', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinact', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}