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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Kardia Mobile®

• Registration Number: NCT06028893
• Lead Sponsor: Ziekenhuis Oost-Limburg

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-08
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-08
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Heart rhythm measurements with FibriCheck®	All subjects will perform heart rhythm measurements with both diagnostic tests.
Study group	Heart rhythm measurements with Kardia Mobile®	All subjects will perform heart rhythm measurements with both diagnostic tests.

Primary Outcome Measures

Name	Time	Method
Specificity	Two months	Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Sensitivity	Two months	Proportion of true positives tests with FibriCheck® out of all patients with AF 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 Outcome Measures

Name	Time	Method
Accuracy by heart rate interval	Two months	Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.
Negative predictive value	Two months	Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Proportion of PPG measurements of insufficient quality for rhythm analysis	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®.
Sensitivity by heart rate interval	Two months	Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.
Specificity by heart rate interval	Two months	Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.
Positive predictive value	Two months	Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.
Proportion of ECG measurements of insufficient quality for rhythm analysis	Two months	ECG measurements by Kardia Mobile®.
Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval	Two months	PPG measurements by FibriCheck®.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium