Validation Study of a Watch for the Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— MOVE-ECG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041466
• Other study ID #: 2019-A00721-56
• Status: Completed
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: July 12, 2019

Study information

• Verified date: August 2019
• Source: Withings
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia, Cardiac
• Atrial Fibrillation

Intervention

Diagnostic Test:
• AF detection by ECG
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG

Locations

Country	Name	City	State
France	Clinique AXIUM Centre de cardiologie	Aix-en-Provence
France	Centre Cardiologique du Nord	Saint-Denis

Sponsors (2)

Lead Sponsor	Collaborator
Withings	Clinact

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF and SR classification accuracy	sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG	1 visit (30 minutes)
Secondary	Quality of the 1-lead ECG strips	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	1 visit (30 minutes)
Secondary	safety evaluation	frequency of adverse events	1 visit (30 minutes)