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
150 participants
INTERVENTIONAL
2024-01-31
2026-03-31
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 and single-lead ECG measurements
Interventions
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FibriCheck recordings
PPG and single-lead ECG measurements
Eligibility Criteria
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Inclusion Criteria
* Access to a smartphone to perform daily measurements
* Ability to understand Dutch
* Atrial Fibrillation diagnosis OR one of the following:
* CHA2DS2-VASc score ≥2 (male) or ≥3 (female)
* Underwent elective cardiac surgery
* Known with:
* Chronic obstructive pulmonary disease
* Obstructive sleep apnea
* Heart Failure
* Hypertension
* Previous stroke or transient ischaemic attack
* Having palpitations and/or racing heart as symptoms
* Other arrhythmia such as atrial flutter, premature atrial contractions (PAC), premature ventricular contractions (PVC)
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
18 Years
ALL
No
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-2023072
Identifier Type: -
Identifier Source: org_study_id
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