Validation Study of an Advanced Blood Pressure Monitor

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Hypertension; Valvular Heart Disease
• Interventions: Diagnostic Test: AF detection; Diagnostic Test: BP measurement; Diagnostic Test: VHD detection

• Registration Number: NCT04030494
• Lead Sponsor: Withings

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-13
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Study First Submitted: 2019-07-19
• Study First Submitted QC: 2019-07-19
• Study First Posted: 2019-07-24
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood pressure (BP)	VHD detection	Group for the validation of blood pressure measurement by the device
Atrial fibrillation (AF)	AF detection	Group for the validation of detection of AF by the device
Atrial fibrillation (AF)	VHD detection	Group for the validation of detection of AF by the device
Valvular heart disease (VHD)	BP measurement	Group for the validation of detection of VHD by the device
Valvular heart disease (VHD)	VHD detection	Group for the validation of detection of VHD by the device
Blood pressure (BP)	BP measurement	Group for the validation of blood pressure measurement by the device
Valvular heart disease (VHD)	AF detection	Group for the validation of detection of VHD by the device

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
safety evaluation	1 visit (1 hour)	frequency of adverse events

Trial Locations

Locations (1)

Clinique AXIUM Centre de cardiologie; 🇫🇷 Aix-en-Provence, France