Creating a database for heart rhythm disorder measurements
The FibriCheck Data Registry
This study is trying to see if a new app can help people with heart rhythm problems, like atrial fibrillation, by collecting daily heart measurements to better understand their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qompium NV Industry-sponsored |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06282393 on ClinicalTrials.gov |
What this trial studies
This interventional clinical trial aims to establish a comprehensive database that includes photoplethysmography (PPG) measurements alongside electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with cardiac arrhythmias. Participants will use the FibriCheck application to perform daily measurements, providing valuable data for assessing heart rhythm disorders. The study focuses on individuals diagnosed with atrial fibrillation or other related conditions, ensuring a structured approach to data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of atrial fibrillation or other specified heart conditions.
Not a fit: Patients currently in follow-up with their physician using the FibriCheck application may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring and management of cardiac arrhythmias, leading to improved patient outcomes.
How similar studies have performed: Other studies utilizing similar approaches with PPG and ECG data have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Pieter Vandervoort, MD — Ziekenhuis Oost-Limburg
- Study coordinator: Lars Grieten, PhD
- Email: lars.grieten@fibricheck.com
- Phone: +3211485953
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.