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OpenTrials
Completed

NCT Number: NCT06282380

Fibricheck Detection cApabilities for Atrial Fibrillation

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

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FibriCheck Mobile Application

Device

PPG measurement with reference diagnosis

Primary outcomes

  1. Accuracy of the FibriCheck Mobile Application

    Time frame: Through study completion: 1 day

    Accuracy based on the reference diagnosis

Secondary outcomes

  1. Sensitivity of the FibriCheck Mobile Application

    Time frame: Through study completion: 1 day

    Sensitivity based on the reference diagnosis

  2. Specificity of the FibriCheck Mobile Application

    Time frame: Through study completion: 1 day

    Specificity based on the reference diagnosis

Sponsors and collaborators

Lead sponsor

Qompium NV

Industry

Registry information

Official study title

Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study

Acronym: FDA-AF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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