Trials
Search / Trial NCT06422468

Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring

Launched by QOMPIUM NV · May 14, 2024

Trial Information

Current as of February 18, 2025

Recruiting

Keywords

Photoplethysmography Single Lead Electrocardiography

ClinConnect Summary

This clinical trial is studying how different types of data collected from smartphones can help understand heart conditions, especially atrial fibrillation (AF). Researchers want to see if combining information from various sensors—like those that measure motion, sound, and heart activity—can give a clearer picture of heart health for people both with and without AF.

The trial is open to adults aged 18 and older who can understand and sign consent forms, with participants being either healthy individuals or those with heart issues. To join, participants should not have certain conditions that might interfere with the measurements, like severe tremors or certain types of tattoos that could affect the sensors. If you decide to participate, you can expect to use a smartphone device that collects these different types of data, helping researchers learn more about heart conditions and improve monitoring in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Inclusion criteria applicable for all groups:
  • At least 18 years old
  • Participants must have the ability to understand and provide written informed consent
  • Participants must have the ability to understand Dutch
  • Group specific inclusion criteria:
  • Group 1: Healthy volunteers
  • No cardiac conditions based on medical history.
  • Group 2: Cardiology patients
  • Patients at the consultation or ambulatory unit of Cardiology (pre- cardioversion, pre-pulmonary vein isolation) with AF.
  • Patients without AF but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction).
  • Exclusion Criteria:
  • 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

Trial Officials

Pieter Vandervoort, MD

Principal Investigator

Ziekenhuis Oost-Limburg

About Qompium Nv

qompium nv is a leading innovative company specializing in digital health solutions that harness the power of technology to enhance patient care and clinical outcomes. Focused on developing advanced software platforms and mobile applications, qompium nv aims to empower healthcare professionals and patients through data-driven insights and real-time monitoring. With a commitment to rigorously conducting clinical trials, qompium nv seeks to validate its solutions in various therapeutic areas, ensuring they meet the highest standards of efficacy and safety. By bridging the gap between healthcare and technology, qompium nv is dedicated to transforming the landscape of patient management and improving overall health outcomes.

Locations

Genk, Limburg, Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0