Clinique AXIUM Centre de cardiologie
Aix-en-Provence, 13090, France
NCT Number: NCT04030494
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aix-en-Provence, 13090, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG
Time frame: 1 visit (30 minutes)
sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram
Time frame: 1 visit (1 hour)
frequency of adverse events
Withings
Industry
Study of Validation of the Advanced Blood Pressure Monitor Withings WPM04 for the Detection of Anomalies of Arterial Pressure, Arrhythmia and Valvular Heart Diseases
Acronym: TALISMAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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