Validation Study of an Advanced Blood Pressure Monitor (TALISMAN)

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Atrial Fibrillation; Valvular Heart Disease
• Intervention / Treatment: Diagnostic test: BP measurement; Diagnostic test: VHD detection; Diagnostic test: AF detection

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13090
    • Clinique AXIUM Centre de cardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood pressure (BP); Group for the validation of blood pressure measurement by the device	Diagnostic test: BP measurement; sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation; Diagnostic test: VHD detection; phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
Other: Atrial fibrillation (AF); Group for the validation of detection of AF by the device	Diagnostic test: VHD detection; phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography; Diagnostic test: AF detection; single lead ECG with Withings WPM04 and 12 lead ECG
Other: Valvular heart disease (VHD); Group for the validation of detection of VHD by the device	Diagnostic test: BP measurement; sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation; Diagnostic test: VHD detection; phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography; Diagnostic test: AF detection; single lead ECG with Withings WPM04 and 12 lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety evaluation	frequency of adverse events	1 visit (1 hour)

Collaborators and Investigators

• Sponsor: Withings
• Collaborators: Clinact

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: atrial fibrillation; blood pressure; Cardiovascular diseases; Heart diseases; electrocardiography; Arrhythmias, Cardiac; Doppler echocardiography; valvular disease; blood pressure monitors
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Atrial Fibrillation; Heart Valve Diseases
• Other Study ID Numbers: 2018-A02847-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No