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

Vilnius University

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

Study type: Observational

Funder types: Other

Identifiers

NCT04281927

S-MIP-17-81

Details and patient eligibility

About

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

Enrollment: 435 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

435 participants in 3 patient groups

Atrial fibrillation

Description:

Patients with presumed atrial fibrillation will undergo monitoring with the device and Holter ECG.

Treatment:

Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

Sinus rhythm

Description:

Patients with presumed sinus rhythm will undergo monitoring with the device and Holter ECG.

Treatment:

Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)

Sinus rhythm and frequent extrasystoles

Description:

Patients with presumed sinus rhythm and frequent extrasystoles will undergo monitoring with the device and Holter ECG.

Treatment:

Device: Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)