FibriCheck Data Registry

Cardiac Arrhythmia Clinical Trial

— FDR  

Official title:

The FibriCheck Data Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282393
• Other study ID #: Z-2023072
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Qompium NV
• Contact: Lars Grieten, PhD
• Phone: +3211485953
• Email: lars.grieten[@]fibricheck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• FibriCheck recordings
PPG and single-lead ECG measurements

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Qompium NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alignment PPG measurement	ECG-PPG alignment (RR-intervals)	14 days