Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 3:41 PM
Study NCT ID:
NCT04030494
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2019-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of an Advanced Blood Pressure Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-07-19', 'lastUpdatePostDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BP precision and accuracy', 'timeFrame': '1 visit (45 minutes)', 'description': 'mean error and standard deviation on measurements, and standard deviation on patients (criteria 1 and 2 of ANSI/AAMI/ISO 81060-2:2013) against sphygmomanometer dual observer auscultation'}, {'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 12-lead ECG'}, {'measure': 'VHD detection accuracy', 'timeFrame': '1 visit (30 minutes)', 'description': 'sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram'}], 'secondaryOutcomes': [{'measure': 'safety evaluation', 'timeFrame': '1 visit (1 hour)', 'description': 'frequency of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure', 'Arrhythmias, Cardiac', 'atrial fibrillation', 'valvular disease', 'blood pressure monitors', 'electrocardiography', 'Doppler echocardiography', 'Heart diseases', 'Cardiovascular diseases'], 'conditions': ['Atrial Fibrillation', 'Hypertension', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders.\n\nThe detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over 18 years old,\n* Subject who signed the consent form,\n* Subject affiliated to a social security scheme or entitled.\n\nExclusion Criteria:\n\n* Underage subject;\n* Subject who refused to participate in the study;\n* Subject participating in other research or clinical studies;\n* Subject with body mass index greater than 35 kg/m2;\n* Subject in linguistic or psychic incapacity to sign an informed consent;\n* Subject with congenital cardiomyopathy;\n* Subject with aorto-venous fistula;\n* Subject with pulmonary pathology that may degrade the quality of the recording;\n* Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;\n* Subject with an arm injury incompatible with the use of an armband sphygmomanometer;\n* Subject receiving an intravenous perfusion on the left arm;\n* Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator;\n* Subject with prosthetic heart valve;\n* Subject under kidney dialysis;\n* Hemodynamically unstable subject (acute heart failure or cardiac assistance).'}, 'identificationModule': {'nctId': 'NCT04030494', 'acronym': 'TALISMAN', 'briefTitle': 'Validation Study of an Advanced Blood Pressure Monitor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Withings'}, 'officialTitle': 'Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases', 'orgStudyIdInfo': {'id': '2018-A02847-48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Blood pressure (BP)', 'description': 'Group for the validation of blood pressure measurement by the device', 'interventionNames': ['Diagnostic Test: BP measurement', 'Diagnostic Test: VHD detection']}, {'type': 'OTHER', 'label': 'Atrial fibrillation (AF)', 'description': 'Group for the validation of detection of AF by the device', 'interventionNames': ['Diagnostic Test: AF detection', 'Diagnostic Test: VHD detection']}, {'type': 'OTHER', 'label': 'Valvular heart disease (VHD)', 'description': 'Group for the validation of detection of VHD by the device', 'interventionNames': ['Diagnostic Test: BP measurement', 'Diagnostic Test: AF detection', 'Diagnostic Test: VHD detection']}], 'interventions': [{'name': 'BP measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation', 'armGroupLabels': ['Blood pressure (BP)', 'Valvular heart disease (VHD)']}, {'name': 'AF detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'single lead ECG with Withings WPM04 and 12 lead ECG', 'armGroupLabels': ['Atrial fibrillation (AF)', 'Valvular heart disease (VHD)']}, {'name': 'VHD detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography', 'armGroupLabels': ['Atrial fibrillation (AF)', 'Blood pressure (BP)', 'Valvular heart disease (VHD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13090', 'city': 'Aix-en-Provence', 'country': 'France', 'facility': 'Clinique AXIUM Centre de cardiologie', 'geoPoint': {'lat': 43.5283, 'lon': 5.44973}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Withings', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Clinact', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}