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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

• Registration Number: NCT04281927
• Lead Sponsor: Vilnius University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Study First Submitted: 2020-01-15
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrial fibrillation	Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)	Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.
Sinus rhythm and frequent extrasystoles	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.
Sinus rhythm	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of a wearable system for atrial fibrillation detection	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 Outcome Measures

Name	Time	Method
Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection	2 minutes.	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.
Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection	Up to 10 months.	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.

Trial Locations

Locations (1)

Vilnius University; 🇱🇹 Vilnius, Lithuania