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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

435 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-06

Study Completion Date

2019-11-15

Brief Summary

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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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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial fibrillation

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

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

Intervention Type 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).

Sinus rhythm

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

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

Intervention Type 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).

Sinus rhythm and frequent extrasystoles

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

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

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.