Identification of Arrhythmias With One-time ECG

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 causes formation of thrombi in the left atrium with ensuing embolization in the cerebral and peripheral circulation.

This study investigates the suitability of measurement techniques and new calculation methods used in sport/wellness technology for the screening and diagnosis of atrial fibrillation and other arrhythmias. New measurement technologies, the one-time ECG measurement and pulse wristband measurement, are studied for their characteristics, data quality and rhythm recognition. Identifying latent arrhythmias with new self-monitoring technologies can significantly reduce the number of strokes (the latent arrhythmias causes about 25% of strokes).

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

Interventions

DEVICE

Heart rhythm monitoring with portable 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. 4. Samsung Gear S3 wearable (Samsung Electronics, Co., Soul, South Korea) which is CE cleared consumer device. Gear S3 is a photopletysmogram, which measures optically the amount of blood circulating in the blood vessel.

Sponsors & Collaborators

• University of Eastern Finland

  collaborator OTHER

• Kuopio University Hospital

  lead OTHER

Principal Investigators

• Tero J Martikainen, MD. PhD · Kuopio University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-28

Primary Completion

2020-02-28

Completion

2020-07-31

Countries

• Finland

Study Locations