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

Withings

Status: Completed

Conditions: Atrial Fibrillation; Arrythmia, Cardiac

Treatments: Diagnostic Test: AF detection by ECG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04041466

2019-A00721-56

Details and patient eligibility

About

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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 3 patient groups

Atrial fibrillation (AF)

Experimental group

Description:

Patients diagnosed with AF during reference ECG

Treatment:

Diagnostic Test: AF detection by ECG

Sinus Rhythm (SR)

Experimental group

Description:

Patients diagnosed with SR during reference ECG

Treatment:

Diagnostic Test: AF detection by ECG

Other Arrythmia

Experimental group

Description:

Patients diagnosed with an arrhythmia other than AF during the reference ECG

Treatment:

Diagnostic Test: AF detection by ECG