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

East Limburg Hospital

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Heart rhythm measurements with FibriCheck®; Diagnostic Test: Heart rhythm measurements with Kardia Mobile®

Study type: Interventional

Funder types: Other

Identifiers

NCT06028893

Z-2021058-2

Details and patient eligibility

About

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®).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Study group

Experimental group

Description:

All subjects will perform heart rhythm measurements with both diagnostic tests.

Treatment:

Diagnostic Test: Heart rhythm measurements with Kardia Mobile®

Diagnostic Test: Heart rhythm measurements with FibriCheck®