NCT06422468RecruitingNot Applicable
Combining Accelerometer, Gyroscope, Sound, Electrocardiography and Photoplethysmography Data in Cardiac Monitoring: a Pilot Study
Qompium NV2 sites in 1 country125 target enrollmentStarted: March 21, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Identification of morphologic characteristics of smartphone generated signals
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Identification of morphologic characteristics of smartphone generated signals
Time Frame: 1 day
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.
Secondary Outcomes
- Evaluate the performance of the FibriCheck Algorithm(1 day)
Investigators
Study Sites (2)
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