NCT04030494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

July 19, 2019

Last Update Submit

August 2, 2019

Conditions

Atrial FibrillationHypertensionValvular Heart Disease

Keywords

blood pressureArrhythmias, Cardiacatrial fibrillationvalvular diseaseblood pressure monitorselectrocardiographyDoppler echocardiographyHeart diseasesCardiovascular diseases

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • safety evaluation

    1 visit (1 hour)

Study Arms (3)

Blood pressure (BP)

OTHER

Group for the validation of blood pressure measurement by the device

Diagnostic Test: BP measurementDiagnostic Test: VHD detection

Atrial fibrillation (AF)

OTHER

Group for the validation of detection of AF by the device

Diagnostic Test: AF detectionDiagnostic Test: VHD detection

Valvular heart disease (VHD)

OTHER

Group for the validation of detection of VHD by the device

Diagnostic Test: BP measurementDiagnostic Test: AF detectionDiagnostic Test: VHD detection

Interventions

BP measurementDIAGNOSTIC_TEST

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

Blood pressure (BP)Valvular heart disease (VHD)
AF detectionDIAGNOSTIC_TEST

single lead ECG with Withings WPM04 and 12 lead ECG

Atrial fibrillation (AF)Valvular heart disease (VHD)
VHD detectionDIAGNOSTIC_TEST

phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography

Atrial fibrillation (AF)Blood pressure (BP)Valvular heart disease (VHD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female over 18 years old,
  • Subject who signed the consent form,
  • Subject affiliated to a social security scheme or entitled.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique AXIUM Centre de cardiologie

Aix-en-Provence, 13090, France

Location

MeSH Terms

Conditions

Atrial FibrillationHypertensionHeart Valve DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 24, 2019

Study Start

March 13, 2019

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)