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®).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.
Measurements are performed immediately before and after every FibriCheck® measurement.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Sensitivity
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Time frame: Two months
Specificity
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Time frame: Two months
Overall accuracy (proportion of correct classifications)
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Time frame: Two months
Positive predictive value
Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Time frame: Two months
Negative predictive value
Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Time frame: Two months
Sensitivity by heart rate interval
Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Time frame: Two months
Specificity by heart rate interval
Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Time frame: Two months
Accuracy by heart rate interval
Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis
PPG measurements by FibriCheck®.
Time frame: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis
ECG measurements by Kardia Mobile®.
Time frame: Two months
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval
PPG measurements by FibriCheck®.
Time frame: Two months
Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval
ECG measurements by Kardia Mobile®.
Time frame: Two months