RecruitingNAINTERVENTIONAL

Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

This study is looking at the best way to treat a fast and irregular heartbeat, called ventricular tachycardia (VT), in people who have scarring on their heart muscle due to previous heart damage. Normally, doctors would only use one treatment method (endocardial ablation) first. However, sometimes the fast heartbeats come back because some of the problem areas are harder to reach. This study wants to see if using two treatment methods (endo-epicardial ablation) together from the very beginning is better at stopping these fast heartbeats from returning. We hope this combined approach will lead to fewer recurrences and improve patients' health.

At a glance

Status

Recruiting

Phase

Sponsor

Rennes University Hospital

Enrolment target

150

Start

23 Oct 2023

Estimated completion

23 Oct 2029

Ischemic Cardiomyopathy Catheter Ablation of Ventricular Tachycardia

What is this study about?

If you have a fast and irregular heartbeat, known as ventricular tachycardia (VT), especially after a heart attack or similar damage, doctors often use a treatment called catheter ablation. This procedure uses heat to carefully destroy the small areas of heart tissue that are causing the irregular beats. While this often works, sometimes the fast heartbeats come back. This can happen because only the inside surface of the heart (the 'endocardium') is treated, but some of the problem areas might be on the outside surface (the 'epicardium').

Currently, if the first treatment on the inside of the heart isn't fully successful, doctors might then try treating the outside. However, some early research suggests that treating both the inside and outside of the heart at the same time, right from the start, might be better at preventing the fast heartbeats from coming back. Preventing these fast heartbeats from returning is really important because they can affect your health and overall well-being.

This study aims to find out if this combined approach, called 'Endo-epicardial ablation', is more effective than only treating the inside of the heart ('endocardial ablation') at preventing VT from coming back. We'll be comparing these two methods as a first-time treatment. Your participation would help us understand the best way to treat this condition to give patients the best chance of staying healthy.

Key takeaways

Compares two ablation methods for fast heart rates.
Aims to reduce fast heart rhythm recurrence.
Combined treatment might be more effective.
Procedure involves heating small heart areas.
Your implanted defibrillator (ICD) will monitor results.

Who may be eligible?

To join this study, you need to be over 18 years old and having your very first catheter ablation procedure for a fast heart rhythm (ventricular tachycardia) that's linked to heart damage from previous heart problems. You also need to have an implanted defibrillator (ICD) and be monitored remotely.

There are certain reasons why you might not be able to join. For example, if you've had previous heart surgery that might make it difficult to reach the outside of your heart or if you have a blood clot inside your heart. You also can't take part if you're pregnant, breastfeeding, or have certain blood clotting issues or medical conditions that prevent you from having a general anaesthetic.

If you're a woman of childbearing age, you'll need to be using effective contraception throughout the study until you leave the hospital after the procedure. Everyone who joins must give their permission in writing and have health insurance or be part of a healthcare system.

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 over 18?
Is this your first ablation for this type of fast heart rhythm?
Do you have an implanted heart device (ICD)?
Have you had heart damage (like from a previous heart attack)?
Have you had heart surgery that might make it tricky to reach parts of your heart?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either have the standard treatment (ablation on the inside of your heart) or the new combined treatment (ablation on both the inside and outside). Which treatment you receive will be decided randomly, like flipping a coin. You won't get to choose which group you are in.

Both procedures are performed in a hospital under general anaesthetic. After your treatment, doctors will monitor you regularly to see if the fast heartbeats return. This monitoring will likely be done through your implanted defibrillator (ICD) that you already have, which can send information remotely to your doctors. The total duration of your participation in the study will involve your hospital stay for the procedure and then ongoing follow-up through your existing device monitoring.

Potential risks and benefits

Taking part in this study might offer you the potential benefit of a reduced chance of your fast heart rhythms returning, particularly if you are in the group receiving the combined treatment. However, all medical procedures carry some risks, and the combined approach might have slightly different or increased risks compared to treating only the inside of the heart. These will be fully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (12)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
Centre Hospitalier Universitaire de Caen
Verified postcode
Caen, France· Not yet recruiting
Centre Hospitalier de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Régional Universitaire de Lille
Verified postcode
Lille, France· Not yet recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Not yet recruiting
CHU de Nantes
Verified postcode
Nantes, France· Recruiting
Hôpital Européen Georges Pompidou
Verified postcode
Paris, France· Recruiting
Hôpital Universitaire La Pitié-Salpêtrière - Paris
Verified postcode
Paris, France· Not yet recruiting
CHU de Rennes
Verified postcode
Rennes, France· Recruiting
Centre Hospitalier Universitaire de Saint-Étienne
Verified postcode
Saint-Etienne, France· Not yet recruiting
Centre Hospitalier Universitaire Toulouse - Hôtel Dieu Saint-Jacques
Verified postcode
Toulouse, France· Not yet recruiting
Centre Hospitalier Régional Universitaire Tours - Hôpital Bretonneau
Verified postcode
Tours, France· Not yet recruiting

Common questions

What is ventricular tachycardia (VT)?

VT is a type of fast and irregular heartbeat that starts in the lower chambers of your heart. It can make you feel dizzy or lightheaded, and is sometimes serious.

What is catheter ablation?

It's a procedure where doctors use a thin, flexible tube (catheter) to deliver heat to small areas of your heart tissue that are causing the irregular beats, to destroy them.

What's the difference between 'endo-epicardial' and 'endocardial-only' ablation?

Endocardial-only means treating just the inside surface of your heart. Endo-epicardial means treating both the inside and outside surfaces of your heart.

Will I know which treatment I'm getting?

No, you won't know beforehand. The treatment you receive will be decided randomly, like picking a name out of a hat, to make the study fair.

How long will the study follow me?

The study will follow your heart rhythm using your existing implanted defibrillator (ICD) after your procedure, which provides continuous monitoring.

How to find out more

Raphaël MARTINS, MD, PhD

raphael.martins@chu-rennes.fr 299282517 Official trial record

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