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

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

• Study Type: Observational
• Enrollment (Actual): 435

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • Vilnius University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atrial fibrillation; Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90); 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).
Sinus rhythm; Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG.	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90); 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).
Sinus rhythm and frequent extrasystoles; Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG.	Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Kaunas University of Technology
• Investigators: Study Chair: Audrius Aidietis, Prof. PhD, Vilnius University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: wearable; photoplethysmography; electrocardiography
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: S-MIP-17-81

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No