REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)

Study Overview
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Brief Summary
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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®).

Official Title
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A Real-World Validation Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Atrial Fibrillation Detection

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Heart rhythm measurements with FibriCheck®
* Diagnostic Test: Heart rhythm measurements with Kardia Mobile®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All subjects will perform heart rhythm measurements with both diagnostic tests. | Diagnostic Test: Heart rhythm measurements with FibriCheck®<br>* Measurements are performed twice daily, starting 4 weeks before a pulmonary vein isolation procedure (PVI) and ending 4 weeks after the PVI.<br>Diagnostic Test: Heart rhythm measurements with Kardia Mobile®<br>* Measurements are performed immediately before and after every FibriCheck® measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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®. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Photoplethysmography, Single-lead ECG, Electrocardiogram, Digital Health