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OpenTrials
Completed

NCT Number: NCT04030494

Validation Study of an Advanced Blood Pressure Monitor

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique AXIUM Centre de cardiologie

Aix-en-Provence, 13090, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

BP measurement

Diagnostic Test

sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation

AF detection

Diagnostic Test

single lead ECG with Withings WPM04 and 12 lead ECG

VHD detection

Diagnostic Test

phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography

Primary outcomes

  1. BP precision and accuracy

    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

  2. AF and SR classification accuracy

    Time frame: 1 visit (30 minutes)

    sensitivity and specificity of detection of AF and SR from 1-lead ECG against 12-lead ECG

  3. VHD detection accuracy

    Time frame: 1 visit (30 minutes)

    sensitivity and specificity of detection of VHD from phonocardiogram against Doppler echocardiogram

Secondary outcomes

  1. safety evaluation

    Time frame: 1 visit (1 hour)

    frequency of adverse events

Sponsors and collaborators

Lead sponsor

Withings

Industry

Collaborators

  • Clinact

Registry information

Official study 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

Acronym: TALISMAN

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2019
Registry last updated
Aug 5, 2019

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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