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Completed

NCT Number: NCT04041466

Validation Study of a Watch 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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Arrythmia, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

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, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

AF detection by ECG

Diagnostic Test

Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. safety evaluation

    Time frame: 1 visit (30 minutes)

    frequency of adverse events

Sponsors and collaborators

Lead sponsor

Withings

Industry

Collaborators

  • Clinact

Registry information

Official study title

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

Acronym: MOVE-ECG

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 1, 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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