Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health
Brief summary
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®).
Interventions
DIAGNOSTIC_TESTHeart rhythm measurements with FibriCheck®
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
DIAGNOSTIC_TESTHeart rhythm measurements with Kardia Mobile®
Measurements are performed immediately before and after every FibriCheck® measurement.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion. * Subject provides informed consent. * Subject understands and agrees to comply with planned study procedures. * Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.
Exclusion criteria
* Insufficient cognitive or comprehensive level of Dutch to participate to the trial. * No access to a smartphone or unable to perform FibriCheck measurements at home. * Pacemaker.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Two months | Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. |
| Specificity | Two months | Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. |
| Overall accuracy (proportion of correct classifications) | Two months | Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity by heart rate interval | Two months | Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®. |
| Accuracy by heart rate interval | Two months | Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®. |
| Proportion of PPG measurements of insufficient quality for rhythm analysis | Two months | PPG measurements by FibriCheck®. |
| Positive predictive value | Two months | Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®. |
| Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval | Two months | PPG measurements by FibriCheck®. |
| Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval | Two months | ECG measurements by Kardia Mobile®. |
| Proportion of ECG measurements of insufficient quality for rhythm analysis | Two months | ECG measurements by Kardia Mobile®. |
| Negative predictive value | Two months | Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®. |
| Sensitivity by heart rate interval | Two months | Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®. |
Countries
Belgium
Outcome results
None listed