Fibricheck Detection cApabilities for Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• 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

Study Timeline

• Study First Submitted: 2024-02-19
• Study Start: 2024-02-26
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-28
• Status Verified: 2024-06
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

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

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)

Northwestern Medicin; 🇺🇸 Chicago, Illinois, United States

New York Presebyterian Queens; 🇺🇸 New York, New York, United States

OU Medicine College; 🇺🇸 Oklahoma City, Oklahoma, United States

University Hospital Antwerp; 🇧🇪 Antwerpen, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium