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

Atrial Fibrillation Clinical Trial

— CARDS-pilot  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422468
• Other study ID #: Z-2023103
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Qompium NV
• Contact: Lars Grieten, PhD
• Phone: +3211485953
• Email: Lars.Grieten[@]fibricheck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• FibriCheck recordings
PPG, ACC, GYR, ECG and sound measurements

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Qompium NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of morphologic characteristics of smartphone generated signals	Detect or identify specific morphologic characteristics (changes or correlations) by the comparison of PPG signals, accelerometer signals, gyroscope signals, sound signals and ECG signals, derived via the smartphone data.	1 day
Secondary	Evaluate the performance of the FibriCheck Algorithm	Evaluate the performance of our PPG FibriCheck Algorithm in cardiology patients and healthy volunteers, based on simultaneously recorded ECG data (RR intervals).	1 day