RecruitingNot ApplicableNCT06422468

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

Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study

Sponsor

Qompium NV

Enrollment

125 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

The goal of this interventional clinical trial is to investigate whether combining photoplethysmography (PPG) signals with accelerometer (ACC), gyroscope (GYR), sound, and electrocardiography (ECG) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (AF).

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 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 Criteria5

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