Trials / Completed
CompletedNCT04030494
Validation Study of an Advanced Blood Pressure Monitor
Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Withings · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | BP measurement | sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation |
| DIAGNOSTIC_TEST | AF detection | single lead ECG with Withings WPM04 and 12 lead ECG |
| DIAGNOSTIC_TEST | VHD detection | phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography |
Timeline
- Start date
- 2019-03-13
- Primary completion
- 2019-06-13
- Completion
- 2019-06-13
- First posted
- 2019-07-24
- Last updated
- 2019-08-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04030494. Inclusion in this directory is not an endorsement.