Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring (CARDS-pilot)

Qompium

Status

Enrolling

Conditions

Atrial Fibrillation

Treatments

Device: FibriCheck recordings

Study type

Interventional

Funder types

Industry

Identifiers

NCT06422468

Z-2023103

Details and patient eligibility

About

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).

Enrollment

125 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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