A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Vilnius University
- Enrollment
- 435
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of a wearable system for atrial fibrillation detection
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
- •Age is between 18 - 99.
Exclusion Criteria
- •Participants who refuse to sign an informed consent.
- •Participants with atrial fibrillation who are currently in a paced rhythm.
Outcomes
Primary Outcomes
Diagnostic accuracy of a wearable system for atrial fibrillation detection
Time Frame: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.
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.
Secondary Outcomes
- Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection(2 minutes.)
- Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection(Up to 10 months.)