Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection (ECG-SW1)

Withings

Status

Unknown

Conditions

Atrial Fibrillation

Treatments

Diagnostic Test: ECG measurement

Study type

Observational

Funder types

Industry

Identifiers

NCT04493749

2019-A013-58-49

Details and patient eligibility

About

Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.

Full description

Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess

The presence or absence of atrial fibrillation
if waveforms of ECG recorded with Move ECG compared with the reference.

Enrollment

234 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male or female who are 18 years or older
Subject who signed the written informed consent form

Exclusion criteria

Vulnerable subject with regard to regulations
Pregnant, parturient or breastfeeding woman,
Subject who is deprived of liberty by judicial, medical or administrative decision,
Underage subject,
Legally protected subject, or subject who is unable to sign the written informed consent form,
Subject who is not beneficiary or not affiliated to a social security scheme,
Subject within several of the above categories,
Subject who refused to participate in the study,
Subject in physical incapacity to wear a wrist-worn watch
Subject with electrical stimulation by pacemaker