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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
218
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
single lead ECG with Withings WPM04 and 12 lead ECG
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, France
BP precision and accuracy
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
Time frame: 1 visit (45 minutes)
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
Time frame: 1 visit (30 minutes)
VHD detection accuracy
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
Time frame: 1 visit (30 minutes)
safety evaluation
frequency of adverse events
Time frame: 1 visit (1 hour)
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