Atrial Fibrillation
Conditions
Brief summary
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
Interventions
DEVICEFibriCheck Mobile Application
PPG measurement with reference diagnosis
Sponsors
Qompium NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 22 years old; * Capable of independently performing FibriCheck recordings (researcher-observed); * Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.
Exclusion criteria
* Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm; * Individuals enrolled in another clinical trial; * Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease; * Pregnant and/or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the FibriCheck Mobile Application | Through study completion: 1 day | Accuracy based on the reference diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the FibriCheck Mobile Application | Through study completion: 1 day | Sensitivity based on the reference diagnosis |
| Specificity of the FibriCheck Mobile Application | Through study completion: 1 day | Specificity based on the reference diagnosis |
Countries
Belgium, United States
Outcome results
None listed