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Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | All subjects will perform heart rhythm measurements with both diagnostic tests. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rhythm measurements with FibriCheck® | Diagnostic Test | Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. | Two months |
| Specificity | Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. | Two months |
| Overall accuracy (proportion of correct classifications) | Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Positive predictive value | Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®. | Two months |
| Negative predictive value | Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
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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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| Heart rhythm measurements with Kardia Mobile® | Diagnostic Test | Measurements are performed immediately before and after every FibriCheck® measurement. |
|
| Two months |
| Sensitivity by heart rate interval | Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. | Two months |
| Specificity by heart rate interval | Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. | Two months |
| Accuracy by heart rate interval | Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. | Two months |
| Proportion of PPG measurements of insufficient quality for rhythm analysis | PPG measurements by FibriCheck®. | Two months |
| Proportion of ECG measurements of insufficient quality for rhythm analysis | ECG measurements by Kardia Mobile®. | Two months |
| Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval | PPG measurements by FibriCheck®. | Two months |
| Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval | ECG measurements by Kardia Mobile®. | Two months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |