Validation Study of an Advanced Blood Pressure Monitor

Hypertension Clinical Trial

— TALISMAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030494
• Other study ID #: 2018-A02847-48
• Status: Completed
• Phase: N/A
• Start date: March 13, 2019
• Est. completion date: June 13, 2019

Study information

• Verified date: August 2019
• Source: Withings
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: June 13, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Diseases
• Heart Valve Diseases
• Hypertension
• Valvular Heart Disease

Intervention

Diagnostic Test:
• BP measurement
sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
• AF detection
single lead ECG with Withings WPM04 and 12 lead ECG
• VHD detection
phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography

Locations

Country	Name	City	State
France	Clinique AXIUM Centre de cardiologie	Aix-en-Provence

Sponsors (2)

Lead Sponsor	Collaborator
Withings	Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	VHD detection accuracy	sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram	1 visit (30 minutes)
Secondary	safety evaluation	frequency of adverse events	1 visit (1 hour)