Fibricheck Detection cApabilities for Atrial Fibrillation (FDA-AF)

Qompium

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: FibriCheck Mobile Application

Study type: Interventional

Funder types: Industry

Identifiers

NCT06282380

FDA-AF study

Details and patient eligibility

About

Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.

Enrollment: 330 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

FibriCheck Mobile Application measurements

Other group

Description:

Participants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth.

Treatment:

Device: FibriCheck Mobile Application