FibriCheck Data Registry (FDR)

February 27, 2024 updated by: Qompium NV

The FibriCheck Data Registry

The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

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 Contact

Study Contact Backup

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost Limburg
        • Contact:

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 18 years old
  • Access to a smartphone to perform daily measurements
  • Ability to understand Dutch

  • Atrial Fibrillation diagnosis OR one of the following:

    • CHA2DS2-VASc score ≥2 (male) or ≥3 (female)
    • Underwent elective cardiac surgery

    • Known with:

      • Chronic obstructive pulmonary disease
      • Obstructive sleep apnea
      • Heart Failure
      • Hypertension
      • Previous stroke or transient ischaemic attack
    • Having palpitations and/or racing heart as symptoms
    • Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)

Exclusion Criteria:

  • Individuals which are currently in follow-up with their physician, using the FibriCheck application
  • Individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device
  • Persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. Parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement
  • Persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow
  • Persons that have a disability to perform the measurements according to the instructions for use
  • Persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

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 recordings
Device: FibriCheck recordings
PPG and single-lead ECG measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alignment PPG measurement
Time Frame: 14 days
ECG-PPG alignment (RR-intervals)
14 days

Collaborators and Investigators

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

Sponsor

Qompium NV

Investigators

  • Principal Investigator: Pieter Vandervoort, MD, Ziekenhuis Oost-Limburg

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)

January 31, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z-2023072

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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