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

NCT ID: NCT06422468

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-21

Study Completion Date

2024-08-01

Brief Summary

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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).

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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FibriCheck recordings

Group Type OTHER

FibriCheck recordings

Intervention Type DEVICE

PPG, ACC, GYR, ECG and sound measurements

Interventions

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FibriCheck recordings

PPG, ACC, GYR, ECG and sound measurements

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qompium NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pieter Vandervoort, MD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

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Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Lars Grieten, PhD

Role: CONTACT

+3211485953

Annelies Geeraerts, PhD

Role: CONTACT

+3211485953

Facility Contacts

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Pieter Vandervoort, MD

Role: primary

089/325050

Other Identifiers

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Z-2023103

Identifier Type: -

Identifier Source: org_study_id

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