Validation Study of a Watch for the Detection of Atrial Fibrillation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04041466

Acronym

MOVE-ECG

Enrollment

140

Registered

2019-08-01

Start date

2019-06-07

Completion date

2019-07-12

Last updated

2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia, Cardiac, Atrial Fibrillation

Keywords

Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography

Brief summary

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).

Interventions

DIAGNOSTIC_TESTAF detection by ECG

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
AF and SR classification accuracy	1 visit (30 minutes)	sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG

Secondary

Measure	Time frame	Description
Quality of the 1-lead ECG strips	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
safety evaluation	1 visit (30 minutes)	frequency of adverse events

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026