FibriCheck Data Registry

Launched by QOMPIUM NV · Feb 27, 2024

Keywords

ClinConnect Summary

The FibriCheck Data Registry is a clinical trial aimed at gathering important information about heart rhythm disorders, specifically focusing on a tool called the FibriCheck Algorithm. This tool uses two types of measurements—one from a method that detects light changes in your finger (called photoplethysmography or PPG) and another from a heart monitor (electrocardiography or ECG). By collecting this data from patients, researchers hope to better understand how this algorithm can help people with conditions like atrial fibrillation, which is a common type of irregular heartbeat.

To join the study, participants need to be at least 18 years old, have a smartphone for daily measurements, and be able to understand Dutch. They should also have a diagnosis of atrial fibrillation or certain related heart issues. While participating, individuals will be asked to take daily measurements using the FibriCheck app. However, the trial is not open to everyone; for example, people with certain disabilities, specific skin conditions, or those who already use the FibriCheck app with their doctor cannot participate. This study offers a chance to contribute to research that could improve heart health monitoring for many people.

Gender

ALL

Eligibility criteria

• 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