Portable Measurement Methods Combined With Artificial Intelligence in Detection of Atrial Fibrillation

Summary

In Western countries, every sixth person in their lifetime and 15,000 people in Finland have a new stroke each year. About every fourth stroke is based on cardiac embolism. Atrial fibrillation (AF) is the most common arrhythmia that increases the risk of thromboembolic complications, such as stroke. It may cause formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation. AF is often asymptomatic and paroxysmal. Thus, the diagnosis of AF is often challenging.

A new onset AF is usually treated with cardioversion (CV), in which the abnormal rhythm is converted back to sinus rhythm (SR). However, a long-lasting AF (\>48 hours) is associated with risk of stroke. Therefore, the duration of AF needs to be known before a CV can be performed. This study evaluates the ability of novel customer-targeted heart measuring devices to detect rhythm change and short AF episodes. Moreover, novel biomarkers will be analyzed from the blood samples of AF patients and their suitability to estimate the duration of AF will be evaluated.

The research will be accomplished in cooperation with the Kuopio University Hospital Emergency Department, the Heart Center, the Department of Applied Physics of the University of Eastern Finland and Heart2Save Ltd.

The results of the research project will be published in the scientific journals of medicine and medical technology and will be presented at scientific conferences of the respective fields. The research results of the project can be utilized by all companies in the medical technology industry, in particular companies that produce ECG measuring instruments and companies that produce rhythm recognition software.

Conditions

• Atrial Fibrillation
• Heart Rate Fast
• Heart Rate Low
• Sinus Rhythm

Interventions

DEVICE

Heart rhythm monitoring with wearable device

The study compares the ability of lightweight measurement methods to detect different heart rhythms compared to the Holter registration. 1. Faros 360 ECG sensor with wet electrodes. Faros 360 Holter is CE and FDA 510 cleared class 2a medical device, which is attached to the patient's chest with five single-use wet electrodes. 2. Suunto Movesense one-time ECG device (Suunto Oy, http://www.suunto.com Vantaa Finland). Movesense is CE cleared consumer device, which is used with two dry electrodes to the ECG measurement. 3. Empatica E4 activity bracelet (Empatica Ltd http://www.empatica.com Milan, Italy), which is CE cleared consumer device. Empatica E4 is a photopletysmogram which measures optically the amount of blood circulating in the blood vessel.

OTHER

Blood samples and biomarkers

Several blood samples will be collected during the study protocol in pre-defined times before and after the cardioversion intervention. Atrial peptides and cardiac troponins will be analyzed and kinetics estimated to predict the duration of early-onset AF period.

Sponsors & Collaborators

• University of Eastern Finland

  collaborator OTHER

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Tero J Martikainen, MD. PhD · Kuopion University Hospital, Anesthesiology and intensive care

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-07

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Finland

Study Locations