Fibricheck Detection cApabilities for Atrial Fibrillation
Not Applicable
Completed
- Conditions
- Atrial Fibrillation
- Interventions
- Device: FibriCheck Mobile Application
- Registration Number
- NCT06282380
- Lead Sponsor
- Qompium NV
- Brief Summary
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FibriCheck Mobile Application measurements FibriCheck Mobile Application Participants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth.
- Primary Outcome Measures
Name Time Method Accuracy of the FibriCheck Mobile Application Through study completion: 1 day Accuracy based on the reference diagnosis
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
University Hospital Antwerp
🇧🇪Antwerpen, Belgium
New York Presebyterian Queens
🇺🇸New York, New York, United States
Northwestern Medicin
🇺🇸Chicago, Illinois, United States
OU Medicine College
🇺🇸Oklahoma City, Oklahoma, United States
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium