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

NCT04281927 | Completed

• 1 other identifier: S-MIP-17-81
• Study Type: observational
• Target: 435
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation

Keywords

wearable; electrocardiography; photoplethysmography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (3)

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)

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)

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)

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).

Atrial fibrillation; Sinus rhythm; Sinus rhythm and frequent extrasystoles

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Participants who refuse to sign an informed consent.
• Participants with atrial fibrillation who are currently in a paced rhythm.

Sponsors & Collaborators

• Vilnius University: lead
• Kaunas University of Technology: collaborator

Study Sites (1)

Vilnius University

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Audrius Aidietis, Prof. PhD

  Vilnius University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: February 24, 2020
• Study Start: March 6, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

LI (1)