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

NCT06422468 | Recruiting

• 1 other identifier: Z-2023103
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Atrial Fibrillation

Keywords

Photoplethysmography; Single-lead Electrocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the performance of the FibriCheck Algorithm

  1 day

Study Arms (1)

FibriCheck recordings

OTHER

Device: FibriCheck recordings

Interventions

FibriCheck recordings DEVICE

PPG, ACC, GYR, ECG and sound measurements

FibriCheck recordings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Qompium NV: lead

Study Sites (1)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter Vandervoort, MD

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Grieten, PhD

CONTACT

+3211485953; Lars.Grieten@fibricheck.com

Annelies Geeraerts, PhD

CONTACT

+3211485953; Annelies.Geeraerts@fibricheck.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: May 21, 2024
• Study Start: March 21, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

BE (1)