Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Atrial Fibrillation Clinical Trial

— ECG-SW1  

Official title:

Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04493749
• Other study ID #: 2019-A013-58-49
• Status: Recruiting
• Start date: December 20, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: July 2020
• Source: Withings
• Contact: Delphine Ladarré
• Phone: +33 6 75 12 23 80
• Email: delphine.ladarre[@]withings.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

1. The presence or absence of atrial fibrillation

2. if waveforms of ECG recorded with Move ECG compared with the reference.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• ECG measurement
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG

Locations

Country	Name	City	State
France	Hopital Europeen Georges Pompidou	Paris	Ile-de-France
France	Institut Cœur Paris Centre Turin	Paris	Ile-de-France
France	Centre Cardiologique du Nord	Saint-Denis	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Withings

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG	sensitivity from the 2x2 confusion matrix AF vs 'non-AF'	1 year
Secondary	Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG	Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate	1 year
Secondary	Safety of use of Move ECG	Frequency of adverse event appearance	1 year