Fibricheck Detection cApabilities for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— FDA-AF  

Official title:

Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282380
• Other study ID #: FDA-AF study
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: May 2024

Study information

• Verified date: May 2024
• Source: Qompium NV
• Contact: Annelies Geeraerts, PhD
• Phone: +3211485953
• Email: Annelies.Geeraerts[@]fibricheck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• FibriCheck Mobile Application
PPG measurement with reference diagnosis

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Antwerpen
Belgium	Ziekenhuis Oost-Limburg	Genk
United States	Northwestern Medicin	Chicago	Illinois
United States	New York Presebyterian Queens	New York	New York
United States	OU Medicine College	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Qompium NV

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of the FibriCheck Mobile Application	Accuracy based on the reference diagnosis	Through study completion: 1 day
Secondary	Sensitivity of the FibriCheck Mobile Application	Sensitivity based on the reference diagnosis	Through study completion: 1 day
Secondary	Specificity of the FibriCheck Mobile Application	Specificity based on the reference diagnosis	Through study completion: 1 day