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| Name | Class |
|---|---|
| Clinact | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure (BP) | Other | Group for the validation of blood pressure measurement by the device |
|
| Atrial fibrillation (AF) | Other | Group for the validation of detection of AF by the device |
|
| Valvular heart disease (VHD) | Other | Group for the validation of detection of VHD by the device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BP measurement | Diagnostic Test | sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| safety evaluation | frequency of adverse events | 1 visit (1 hour) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique AXIUM Centre de cardiologie | Aix-en-Provence | 13090 | France |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| D006349 | Heart Valve Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| AF detection | Diagnostic Test | single lead ECG with Withings WPM04 and 12 lead ECG |
|
| VHD detection | Diagnostic Test | phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography |
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