RecruitingNAINTERVENTIONAL

Relevance of Recording an ECG Trace With a Connected Watch

This study is exploring how useful smartwatches are for checking your heart's electrical activity. Many smartwatches now have a feature that can record an "ECG" (electrocardiogram), which gives information about your heart rhythm. Doctors want to see how accurate these smartwatch readings are compared to the classic, more detailed ECG machines used in hospitals. The researchers will compare smartwatch readings with standard hospital ECGs in both healthy individuals and people with various heart conditions. They also hope to collect enough data to develop a smart artificial intelligence (AI) system that can automatically analyse smartwatch ECGs. Part of the study also involves checking if these smartwatch ECGs work well for children.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

3,000

Start

26 Mar 2024

Estimated completion

26 Mar 2028

Arrhythmias, Cardiac

What is this study about?

Heart rhythm problems, sometimes called arrhythmias, mean your heart beats too fast, too slow, or in an irregular way. Getting an accurate picture of your heart's electrical activity is key to understanding and managing these conditions. Traditionally, this is done with an ECG (electrocardiogram) machine in a clinic or hospital, which uses many wires and sensors to get a very detailed reading.

More recently, some smartwatches have been developed that can also record a basic ECG. While these smartwatch ECGs give less detail than a hospital machine, they can be useful for quickly checking your heart rhythm when you're at home or out and about. This study wants to find out exactly how reliable these smartwatch ECGs are.

The main goal is to see if smartwatch ECGs capture the same important information as a hospital ECG, especially in people with different heart conditions. Researchers will also collect a large amount of data to help create and test a new computer program (artificial intelligence) that can automatically analyse smartwatch ECGs. They're also checking if these watches can be used effectively to record heart activity in children.

Key takeaways

The study explores how well smartwatches can measure heart rhythms.
It compares smartwatch ECGs to traditional hospital ECGs.
Data will help create AI to interpret smartwatch readings.
Both healthy people and those with heart conditions are included.
Children can also participate in the study.
Participation involves simple, non-invasive heart measurements.

Who may be eligible?

To be part of this study, you would need to be a patient seen at the Haut Lévêque cardiology hospital, either because you're staying there or have an appointment. This study is open to both adults and children, from newborn up to 18 years old, and people of all genders.

It's very important that you (or your legal parent if you're under 18) freely agree to take part and sign a consent form. You also need to be covered by a social security system.

However, you cannot take part if you are unable to give consent yourself, if you are under legal protection like guardianship, or if you are in prison or similar situations where your freedom is restricted.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I a patient at Haut Lévêque cardiology hospital?
Am I able to give my full, written consent (or can my legal parent/guardian)?
Am I covered by a social security system?
Am I not under any legal protection measure (like guardianship) or in prison?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have your heart's electrical activity measured using two different methods: a standard hospital ECG machine with 12 sensors (which is the reference) and also a smartwatch that records either 1 or 6 points of electrical activity. This will be done on one occasion, and there are no specific medications involved as part of the study. The total duration of your involvement would be limited to the time taken for these measurements during your hospital visit or stay.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to our understanding of how useful smartwatches are for monitoring heart health, potentially improving future care for many people. There are no known significant risks as the tests involved (standard ECG and smartwatch ECG) are both non-invasive and routine procedures that do not cause harm. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Hôpital Haut-Lévèque
Verified postcode
Pessac, France· Recruiting

Common questions

What is an ECG?

An ECG (electrocardiogram) is a simple and painless test that records the electrical signals from your heart, showing how fast it's beating and if it has a regular rhythm.

Why is this study comparing smartwatches to hospital ECGs?

This study wants to see how accurate and reliable smartwatch ECGs are compared to the detailed ECGs doctors use in hospitals, especially for spotting different heart rhythm problems.

Will taking part in this study change my heart treatment?

No, taking part in this study will not change your current heart treatment or medical care. It's about collecting data to learn more about how smartwatches work.

Can children join this study?

Yes, children of all ages (from birth up to 18 years old) can take part, as long as their legal parent or guardian gives consent.

What is 'artificial intelligence' in this study?

Artificial intelligence (AI) here means a smart computer program that will be trained to automatically analyse the ECG readings from smartwatches and help doctors understand them.

How to find out more

Pierre BORDACHAR

pierre.bordachar@chu-bordeaux.fr +335 57 65 64 71 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.