Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Withings
- Enrollment
- 218
- Locations
- 1
- Primary Endpoint
- AF and SR classification accuracy
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
The 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female over 18 years old,
- •Subject who signed the consent form,
- •Subject affiliated to a social security scheme or entitled.
Exclusion Criteria
- •Underage subject;
- •Subject who refused to participate in the study;
- •Subject participating in other research or clinical studies;
- •Subject with body mass index greater than 35 kg/m2;
- •Subject in linguistic or psychic incapacity to sign an informed consent;
- •Subject with congenital cardiomyopathy;
- •Subject with aorto-venous fistula;
- •Subject with pulmonary pathology that may degrade the quality of the recording;
- •Subject presenting a serious pathology compromising the realization of the examinations envisaged in the test;
- •Subject with an arm injury incompatible with the use of an armband sphygmomanometer;
Outcomes
Primary Outcomes
AF and SR classification accuracy
Time Frame: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
VHD detection accuracy
Time Frame: 1 visit (30 minutes)
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
BP precision and accuracy
Time Frame: 1 visit (45 minutes)
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
Secondary Outcomes
- safety evaluation(1 visit (1 hour))