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

Atrial Fibrillation Clinical Trial

— RELATION PPG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06028893
• Other study ID #: Z-2021058-2
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Heart 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.
• Heart rhythm measurements with Kardia Mobile®
Measurements are performed immediately before and after every FibriCheck® measurement.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.	Two months
Primary	Specificity	Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.	Two months
Primary	Overall accuracy (proportion of correct classifications)	Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.	Two months
Secondary	Positive predictive value	Positive predictive value of FibriCheck® measurements relative to Kardia Mobile®.	Two months
Secondary	Negative predictive value	Negative predictive value of FibriCheck® measurements relative to Kardia Mobile®.	Two months
Secondary	Sensitivity by heart rate interval	Proportion of true positives tests with FibriCheck® out of all patients with AF on Kardia Mobile®.	Two months
Secondary	Specificity by heart rate interval	Proportion of true negative tests with FibriCheck® out of all patients in sinus rhythm on Kardia Mobile®.	Two months
Secondary	Accuracy by heart rate interval	Proportion of correct classifications with FibriCheck®. Correct classification is provided by Kardia Mobile®.	Two months
Secondary	Proportion of PPG measurements of insufficient quality for rhythm analysis	PPG measurements by FibriCheck®.	Two months
Secondary	Proportion of ECG measurements of insufficient quality for rhythm analysis	ECG measurements by Kardia Mobile®.	Two months
Secondary	Proportion of PPG measurements of insufficient quality for rhythm analysis by heart rate interval	PPG measurements by FibriCheck®.	Two months
Secondary	Proportion of ECG measurements of insufficient quality for rhythm analysis by heart rate interval	ECG measurements by Kardia Mobile®.	Two months