An observational study in Atrial Fibrillation, sponsored by Vilnius University. Completed at 1 site in Lithuania. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by Vilnius University · Observational
A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).
3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.
This study's enrollment of 435 is above the median of 300 across 1,364 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Vilnius University is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.
Exclusion Criteria:
Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.
Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG.
Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG.
Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)
Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).
Diagnostic accuracy of a wearable system for atrial fibrillation detection
The wearable system comprises of two integrated components: a photoplethysmography (PPG) and a 6-lead ECG of the device. It works as described below. First, an automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. Next, a 6-lead ECG is acquired by the wearable. The rhythm assessment of ECG is based on P waves and regularity of QRS complexes. A diagnosis is made by independent cardiologists. The conclusion of a whole system comprising of both described methods will be compared with a gold standard multi-lead Holter ECG. This standard ECG is also evaluated by independent cardiologists.
Time frame: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.
Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection
An automatic PPG algorithm will indicate whether atrial fibrillation is suspected. The rhythm assessment of PPG algorithm is based on pulse regularity. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is assessed by independent cardiologists.
Time frame: 2 minutes.
Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection
Independent cardiologists will assess the heart rhythm in a 6-lead ECG acquired by the wearable. As a separate diagnostic tool it will be compared with a gold standard multi-lead Holter ECG which is also assessed by independent cardiologists. The rhythm evaluation of ECG is based on P waves and regularity of QRS complexes.
Time frame: Up to 10 months.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Vilnius University