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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
140
Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
Clinique AXIUM Centre de cardiologie
Aix-en-Provence, France
Centre Cardiologique du Nord
Saint-Denis, France
AF and SR classification accuracy
sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG
Time frame: 1 visit (30 minutes)
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
Time frame: 1 visit (30 minutes)
safety evaluation
frequency of adverse events
Time frame: 1 visit (30 minutes)
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