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Completed

NCT Number: NCT04281927

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University

Vilnius, Lithuania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection

    Time frame: 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.

  2. Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Kaunas University of Technology

Registry information

Acronym: DoubleCheckAF

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2020
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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