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The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Sinus Rhythm | Experimental | Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices |
|
| Atrial Fibrillation | Experimental | Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices |
|
| Arrhythmia other than Atrial Fibrillation | Experimental | Simultaneous ECG recording of patient with Arrhythmia other than Atrial Fibrillation with investigational and reference devices |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Device (Withings SCT02) 30 second Electrocardiogram recording | Device | 30 second ECG recording with investigational device (Withings SCT02) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary outcome 1 - Sensitivity of Investigational Device | Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG. | 10 months |
| Co-primary outcome 2 - Specificity of Investigational Device | Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rhythm classification by ranges of heart rate | On pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the IMD is classified as either SR or AF, the classification into four heart rate subgroups will be evaluated.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FWD Clinical Research | Boca Raton | Florida | 33486 | United States | ||
| Diverse Clinical Research |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording | Device | 30 second ECG recording with reference device (Schiller Cardiovit FT-1) |
|
| 10 months |
| Quality of plots measured by the IMD - ECG Waveform Visibility | Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FV : Fraction of concordant assessments of visibility between the IMD and the reference | 10 months |
| Quality of plots measured by the IMD - ECG Waveforms Polarity | On waveforms with waves that are Visible, Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FP : Fraction of concordant assessment of polarity between IMD and reference | 10 months |
| Quality of plots measured by the IMD - ECG Waveforms Intervals | Determine the equivalence of PR, QRS and QT intervals durations between the lead I of the IMD and the lead I of the reference ECG determined by an independent board of certified cardiologists. Duration error will be calculated. | 10 months |
| Quality of plots measured by the IMD - Heart Rate calculation | Determine the equivalence of the heart rate (HR) calculated by the IMD and the HR measured by an independent board of certified cardiologists or cardiology technicians on the ECG of the reference. | 10 months |
| Miami |
| Florida |
| 33175 |
| United States |
| Henri Mondor University Hospital | Créteil | Val de Marne | 94000 | France |
| Centre Cardiopole Trubert | Paris | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |