RecruitingNAINTERVENTIONAL

A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

This study is exploring a new way to help people with irregular heartbeats. Doctors use a special, thin tube called a 'mapping catheter' to create a detailed map of the heart's electrical activity. This helps them pinpoint exactly where the abnormal rhythms, like atrial fibrillation or ventricular tachycardia, are starting. The purpose of this research is to check if this new type of mapping catheter is safe to use and if it can effectively create these important maps in both the upper and lower chambers of the heart. By doing this, the study hopes to improve how doctors understand and treat these heart conditions, potentially leading to better outcomes for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Biosense Webster, Inc.

Enrolment target

Start

15 Sep 2025

Estimated completion

30 Sep 2026

What is this study about?

If you have an irregular heartbeat, like atrial fibrillation or ventricular tachycardia, your doctor might suggest a procedure called catheter ablation. This procedure helps to stop the irregular heartbeats by finding and treating the exact spot in your heart where they start.

Before an ablation, doctors need to create a very detailed 'map' of your heart's electrical activity. They do this by gently guiding a thin, flexible tube called a 'catheter' into your heart. This catheter has tiny sensors that record the electrical signals. This study is testing a new type of mapping catheter. It's designed to be very precise and gather a lot of information quickly.

The main goal is to find out if this new mapping catheter is safe for patients and if it can successfully create these detailed maps of both the upper (atria) and lower (ventricles) chambers of the heart. By getting a clearer picture of your heart's electrical activity, doctors can better understand your specific heart rhythm problem and plan the most effective treatment.

Key takeaways

This study is testing a new device to map irregular heartbeats.
It aims to see if the device is safe and works well for accurate heart mapping.
Participation involves a procedure similar to standard heart mapping.
It focuses on conditions like atrial fibrillation and ventricular tachycardia.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with certain irregular heartbeats, such as atrial fibrillation, atrial tachycardia, ventricular tachycardia, or frequent premature ventricular contractions. You would need to be considered suitable for a procedure to map your heart and potentially treat these rhythms with ablation.

To join, your irregular heartbeat must have been officially recorded by tests like an ECG within the last year. You must also be able to understand the study information and agree to take part, as well as attend all required appointments before, during, and after the study.

There are some reasons you might not be able to join. For example, if your heart rhythm problem is due to something that can be easily fixed (like an imbalance in body salts), or if you already have certain heart conditions like very poor heart function (low ejection fraction). Also, conditions like a recent heart attack, stroke, or severe allergies to dyes used in medical tests would prevent you from taking part.

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?
Do you have a diagnosis of an irregular heartbeat like atrial fibrillation or ventricular tachycardia?
Has your irregular heartbeat been confirmed by tests in the last year?
Are you considered suitable for a procedure to map your heart's electrical activity?
Do you have good overall heart function (not severely weakened)?
Have you not had a recent heart attack or stroke?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will use the new mapping catheter to create a detailed map of your heart's electrical activity during a planned procedure. This procedure is similar to a standard heart mapping procedure, with the main difference being the specific catheter used. You will have regular checks and follow-up appointments after the procedure to see how you are doing. The total duration of your participation, including follow-up, will be discussed in detail by the study team.

Potential risks and benefits

Taking part in this study could help doctors better understand your heart condition and plan your treatment, potentially leading to a more effective procedure. However, as with any medical procedure involving catheters, there are potential risks, such as bleeding, infection, or other reactions. The study team will explain all known or possible risks in detail. Remember, your participation is completely voluntary, and you can choose to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (6)

AZ Sint-Jan
Verified postcode
Bruges, Belgium· Recruiting
Jessa Ziekenhuis
Verified postcode
Hasselt, Belgium· Recruiting
Hopital les Franciscaines of Nimes
Verified postcode
Nîmes, France· Withdrawn
CHU de Bordeaux - Hospital Haut-Leveque
Verified postcode
Pessac, France· Recruiting
Chu Rennes Hopital Pontchaillou
Verified postcode
Rennes, France· Recruiting
Vilnius University Hospital Santaros Clinics
Verified postcode
Vilnius, Lithuania· Recruiting

Common questions

What is a multi-electrode mapping catheter?

It's a special thin tube, like a wire, with many sensors on it. Doctors put it into your heart to get a very detailed picture of its electrical activity, helping them find where irregular heartbeats start.

Why is this study important?

This study helps find out if a new, more advanced mapping catheter is safe and effective. If it is, it could help doctors get better information about irregular heartbeats, leading to better treatment for patients.

Will I get any new medicine in this study?

No, this study is about a special device (the catheter), not new medicines. You will continue to receive any medication prescribed by your doctor.

What are 'atrial fibrillation' and 'ventricular tachycardia'?

These are types of irregular heartbeats. Atrial fibrillation affects the upper chambers of your heart, while ventricular tachycardia affects the lower chambers. Both can make your heart beat too fast or irregularly.

Will this study cure my heart condition?

This study aims to improve the mapping process that helps doctors treat your condition, but it's not a cure in itself. It contributes to making future treatments more effective.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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