RecruitingOBSERVATIONAL

Non-invasive Differentiation of Supraventricular Tachyarrhythmia

This study explores new, non-invasive ways to better understand and diagnose irregular heartbeats, also known as supraventricular tachyarrhythmias, including atrial fibrillation. Researchers are using two main tools: detailed questionnaires to learn about personal triggers and symptoms of these heart conditions, and a special, highly detailed heart tracing called an extended high-resolution ECG. This advanced ECG can pick up tiny heart signals that a standard ECG might miss, helping doctors identify specific types of irregular heart rhythms more accurately. The goal is to improve how these conditions are diagnosed and understood, especially in people who are already scheduled for treatment to correct their heart rhythm.

At a glance

Status

Recruiting

Sponsor

RWTH Aachen University

Enrolment target

1,250

Start

01 Sep 2021

Estimated completion

30 Sep 2026

Supraventricular Arrhythmia Atrial Fibrillation

What is this study about?

This study is looking for better ways to figure out and understand different types of irregular heartbeats, which doctors call "supraventricular tachyarrhythmias." This includes common conditions like atrial fibrillation, where the heart beats too fast and unevenly. Currently, it can be tricky to tell exactly which type of irregular heartbeat someone has and what might be causing it.

The researchers are trying out two main approaches. First, they are using detailed questionnaires. These aren't just simple questions; they ask about specific everyday situations, behaviours (like stress, alcohol, or even changing positions), and other factors that might start or stop an irregular heartbeat. By gathering this kind of information, the study hopes to create a more systematic way of understanding what triggers these heart issues in different people.

Secondly, the study uses a very special and sensitive heart tracing test, called an "extended high-resolution ECG." You might be familiar with a standard ECG, which is a quick test to check your heart's electrical activity. This extended ECG is much more detailed. It's recorded over several minutes with extra sensors placed specifically to pick up tiny electrical signals from the upper chambers of your heart. It can detect subtle patterns that a regular ECG might miss, helping doctors get a clearer picture of your heart's rhythm and identify specific problems more accurately, all without needing to go inside the body.

Key takeaways

The study investigates new ways to diagnose irregular heartbeats accurately.
It uses detailed questionnaires and a special, high-resolution heart tracing (ECG).
Participation is for adults already scheduled for an ablation procedure.
The study is non-invasive and does not involve new medications.
Results could help improve future diagnosis and understanding of heart rhythm problems.

Who may be eligible?

This study is looking for adult patients (18 years and older) who are already planning to have a procedure called an "ablation" to correct an irregular heartbeat. This includes various types of fast heart rhythms originating from the top chambers of the heart, such as atrial fibrillation or atrial flutter.

There are some reasons why you might not be able to join. For example, if you are very unwell and need intensive care, or if you have difficulty with language or understanding that would make it hard to answer the detailed questions properly, you wouldn't be able to participate. Also, if you have lots of other competing heart rhythm problems (more than 5% of your heartbeats being extra beats) that would make the readings unclear, this study might not be right for you.

Specific reasons for not being able to take part in the special ECG part of the study include having had a previous ablation for atrial fibrillation in the exact same spot, having an implanted electrical device like a pacemaker or defibrillator, or being allergic to the sticky pads used for the ECG sensors.

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.

Are you 18 years old or older?
Are you scheduled for an 'ablation' procedure for an irregular heartbeat?
Do you feel well enough to participate and answer questions?
Do you not have a pacemaker or other implanted electrical device?
Are you able to speak and understand English clearly?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to complete some detailed questionnaires. These will focus on your personal experiences with your irregular heartbeat, including potential triggers and what might stop the episode. You'll also complete two standard questionnaires used to classify your symptoms.

You will also have a special, extended heart tracing (ECG) recorded. This is similar to a regular ECG but uses more sensors and takes a bit longer, several minutes, to get a very detailed picture of your heart's electrical signals. There are no medications or follow-up visits specifically required for this study beyond your standard medical care. The total duration of your participation will depend on when you complete the questionnaires and have the extended ECG recorded, which will typically happen around the time of your planned ablation procedure.

Potential risks and benefits

Participating in this study might offer a small benefit by contributing valuable information that could help doctors better understand and diagnose irregular heartbeats in the future. There are no direct medical benefits to you personally. The main risks are minimal; the questionnaires might take some time to complete, and the extended ECG is a non-invasive test similar to a standard ECG, so it carries very little risk, other than potential mild skin irritation from the sticky pads. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

RWTH Aachen University
Verified postcode
Aachen, Germany· Recruiting

Common questions

What is an 'irregular heartbeat'?

An irregular heartbeat means your heart isn't beating in its usual steady rhythm, sometimes too fast or unevenly. Doctors call these 'arrhythmias'.

What is an 'ablation'?

An ablation is a procedure doctors use to correct irregular heartbeats by carefully targeting and treating the small areas in your heart that are causing the problem.

Is the 'extended ECG' painful?

No, the extended ECG is not painful. It's a simple, non-invasive test where sticky pads are placed on your skin to record your heart's electrical activity.

Will this study change my treatment?

No, participating in this study will not change your planned medical treatment or ablation procedure. It's for research purposes to gather more information.

Do I have to answer all the questionnaire questions?

It's best to answer as many as you can, as the information helps the researchers understand irregular heartbeats better. However, you can discuss any concerns with the study team.

How to find out more

Matthias D Zink, MD

mzink@ukaachen.de 00492418035113 Official trial record

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