A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection

N/ACompletedNCT04281927

Vilnius University435 enrolled

Overview

A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).

Study Type

OBSERVATIONAL

Enrollment

435

Conditions

Atrial Fibrillation

Interventions

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vilnius University

Vilnius, Lithuania

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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