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

Atrial Fibrillation Clinical Trial

— DoubleCheckAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281927
• Other study ID #: S-MIP-17-81
• Status: Completed
• Start date: March 6, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: February 2021
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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).

Locations

Country	Name	City	State
Lithuania	Vilnius University	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Kaunas University of Technology

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.