Validation Study of a Watch for the Detection of Atrial Fibrillation

Study Overview
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Brief Summary
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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).

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

Conditions
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Atrial Fibrillation, Arrythmia, Cardiac

Intervention / Treatment
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* Diagnostic Test: AF detection by ECG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atrial fibrillation (AF)<br>Patients diagnosed with AF during reference ECG | Diagnostic Test: AF detection by ECG<br>* Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG<br>|
| Experimental: Sinus Rhythm (SR)<br>Patients diagnosed with SR during reference ECG | Diagnostic Test: AF detection by ECG<br>* Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG<br>|
| Experimental: Other Arrythmia<br>Patients diagnosed with an arrhythmia other than AF during the reference ECG | Diagnostic Test: AF detection by ECG<br>* Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| safety evaluation | frequency of adverse events | 1 visit (30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular diseases, Heart diseases, Wearable Electronic Devices, Electrocardiography