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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06282380
Other study ID # FDA-AF study
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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