Validation Study of an Advanced Blood Pressure Monitor

Study Overview
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Brief Summary
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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.

Official Title
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Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases

Conditions
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Atrial Fibrillation, Hypertension, Valvular Heart Disease

Intervention / Treatment
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* Diagnostic Test: BP measurement
* Diagnostic Test: AF detection
* Diagnostic Test: VHD detection


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Blood pressure (BP)<br>Group for the validation of blood pressure measurement by the device | Diagnostic Test: BP measurement<br>* sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation<br>Diagnostic Test: VHD detection<br>* phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography<br>|
| Other: Atrial fibrillation (AF)<br>Group for the validation of detection of AF by the device | Diagnostic Test: AF detection<br>* single lead ECG with Withings WPM04 and 12 lead ECG<br>Diagnostic Test: VHD detection<br>* phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography<br>|
| Other: Valvular heart disease (VHD)<br>Group for the validation of detection of VHD by the device | Diagnostic Test: BP measurement<br>* sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation<br>Diagnostic Test: AF detection<br>* single lead ECG with Withings WPM04 and 12 lead ECG<br>Diagnostic Test: VHD detection<br>* phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 visit (30 minutes) | 
| VHD detection accuracy | sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram | 1 visit (30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety evaluation | frequency of adverse events | 1 visit (1 hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood pressure, Arrhythmias, Cardiac, atrial fibrillation, valvular disease, blood pressure monitors, electrocardiography, Doppler echocardiography, Heart diseases, Cardiovascular diseases