Cardiac Arrhythmia
Conditions
Keywords
Photoplethysmography, Single-lead electrocardiography
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.
Interventions
DEVICEFibriCheck recordings
PPG and single-lead ECG measurements
Sponsors
Qompium NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alignment PPG measurement | 14 days | ECG-PPG alignment (RR-intervals) |
Countries
Belgium
Contacts
Primary ContactLars Grieten, PhD
Backup ContactAnnelies Geeraerts, PhD
Outcome results
None listed