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| Name | Class |
|---|---|
| Kaunas University of Technology | OTHER |
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A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation | Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG. |
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| Sinus rhythm | Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG. |
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| Sinus rhythm and frequent extrasystoles | Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.
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| Name | Affiliation | Role |
|---|---|---|
| Audrius Aidietis, Prof. PhD | Vilnius University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University | Vilnius | Lithuania |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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| 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. | Up to 10 months. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |