Atrial Fibrillation, Hypertension, Valvular Heart Disease
Conditions
Keywords
blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases, Cardiovascular diseases
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.
Interventions
DIAGNOSTIC_TESTBP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
DIAGNOSTIC_TESTAF detection
single lead ECG with Withings WPM04 and 12 lead ECG
DIAGNOSTIC_TESTVHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Sponsors
Clinact
Withings
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * Subject receiving an intravenous perfusion on the left arm; * Subject with electrical stimulation by pacemaker, implantable cardioverter-defibrillator; * Subject with prosthetic heart valve; * Subject under kidney dialysis; * Hemodynamically unstable subject (acute heart failure or cardiac assistance).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BP precision and accuracy | 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 |
| AF and SR classification accuracy | 1 visit (30 minutes) | sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG |
| VHD detection accuracy | 1 visit (30 minutes) | sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety evaluation | 1 visit (1 hour) | frequency of adverse events |
Countries
France
Outcome results
None listed