Fibricheck Detection cApabilities for Atrial Fibrillation (FDA-AF)

June 26, 2024 updated by: Qompium NV

Fibricheck Detection cApabilities for Atrial Fibrillation - a Multicenter Validation Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2000
        • University Hospital Antwerp
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg
  • United States
    • Illinois
      • Chicago, Illinois, United States, 12251
        • Northwestern Medicin
    • New York
      • New York, New York, United States, 11355
        • New York Presebyterian Queens
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73001
        • OU Medicine College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FibriCheck Mobile Application measurements
Participants will perform one measurement using the FibriCheck Mobile Application and the result will be compared with the ground truth.
Device: FibriCheck Mobile Application
PPG measurement with reference diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the FibriCheck Mobile Application
Time Frame: Through study completion: 1 day
Accuracy based on the reference diagnosis
Through study completion: 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of the FibriCheck Mobile Application
Time Frame: Through study completion: 1 day
Sensitivity based on the reference diagnosis
Through study completion: 1 day
Specificity of the FibriCheck Mobile Application
Time Frame: Through study completion: 1 day
Specificity based on the reference diagnosis
Through study completion: 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qompium NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

June 26, 2024

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDA-AF study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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