Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring
NCT ID: NCT06422468
Last Updated: 2024-05-21
Study Results
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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RECRUITING
NA
125 participants
INTERVENTIONAL
2024-03-21
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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FibriCheck recordings
FibriCheck recordings
PPG, ACC, GYR, ECG and sound measurements
Interventions
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FibriCheck recordings
PPG, ACC, GYR, ECG and sound measurements
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Qompium NV
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Z-2023103
Identifier Type: -
Identifier Source: org_study_id
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