FibriCheck Data Registry

Not Applicable

Recruiting

• Conditions: Cardiac Arrhythmia
• Interventions: Device: FibriCheck recordings

• Registration Number: NCT06282393
• Lead Sponsor: Qompium NV

Brief Summary

The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• At least 18 years old

• Access to a smartphone to perform daily measurements

• Ability to understand Dutch

• Atrial Fibrillation diagnosis OR one of the following:

  • CHA2DS2-VASc score ≥2 (male) or ≥3 (female)

  • Underwent elective cardiac surgery

  • Known with:

    • Chronic obstructive pulmonary disease
    • Obstructive sleep apnea
    • Heart Failure
    • Hypertension
    • Previous stroke or transient ischaemic attack

  • Having palpitations and/or racing heart as symptoms

  • Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)

Exclusion Criteria

• Individuals which are currently in follow-up with their physician, using the FibriCheck application
• Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
• Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
• Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
• Persons that have a disability to perform the measurements according to the instructions for use
• Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FibriCheck recordings	FibriCheck recordings	-

Primary Outcome Measures

Name	Time	Method
Alignment PPG measurement	14 days	ECG-PPG alignment (RR-intervals)

Trial Locations

Locations (1)

Ziekenhuis Oost Limburg; 🇧🇪 Genk, Limburg, Belgium