Validation Study of a Watch for the Detection of Atrial Fibrillation (MOVE-ECG)

August 2, 2019 updated by: Withings

Validation of the Watch Withings HWA08 for the Detection of Atrial Fibrillation

The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-en-Provence, France, 13090
        • Clinique AXIUM Centre de cardiologie
      • Saint-Denis, France, 93200
        • Centre Cardiologique du Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • adults, men or women, at least 18 years old
  • person having signed the informed consent form
  • person affiliated to a social security system

Exclusion Criteria:

  • vulnerable subject according to current regulation:

    • pregnant woman, parturient or breastfeeding
    • subject deprived of freedom by judicial, medical or administrative decision
    • subject legally protected or unable to express his consent
    • subject non-beneficiary of healthcare
    • subject falling into more than one of the above categories
  • subject who refused to participate in the study
  • subject in linguistic or psychic incapacity to sign a written informed consent form
  • subject in physical incapacity to wear a watch on their wrist
  • subject with electrical stimulation by pacemaker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atrial fibrillation (AF)
Patients diagnosed with AF during reference ECG
Diagnostic test: AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Experimental: Sinus Rhythm (SR)
Patients diagnosed with SR during reference ECG
Diagnostic test: AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Experimental: Other Arrythmia
Patients diagnosed with an arrhythmia other than AF during the reference ECG
Diagnostic test: AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 reference 12-lead ECG
1 visit (30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the 1-lead ECG strips
Time Frame: 1 visit (30 minutes)
sensitivity and specificity of detection of AF and SR from 1-lead ECG strips reviewed by a blind, trained cardiologist against reference 12-lead ECG
1 visit (30 minutes)
safety evaluation
Time Frame: 1 visit (30 minutes)
frequency of adverse events
1 visit (30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Withings

Collaborators

Clinact

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2019

Primary Completion (Actual)

July 12, 2019

Study Completion (Actual)

July 12, 2019

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A00721-56

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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