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Validation Study of an Advanced Blood Pressure Monitor

NCT04030494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2019-08-05

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

BP measurement

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

DIAGNOSTIC_TEST

AF detection

single lead ECG with Withings WPM04 and 12 lead ECG

DIAGNOSTIC_TEST

VHD detection

phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography

Sponsors & Collaborators

  • Clinact

    collaborator OTHER

  • Withings

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-13
Primary Completion
2019-06-13
Completion
2019-06-13

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030494 on ClinicalTrials.gov