RecruitingNAINTERVENTIONAL

International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction

This research is looking into different treatments for people who have abnormal heart rhythms (called ventricular tachycardia) due to heart disease. Specifically, it focuses on patients whose heart function is still quite good and whose heart rhythm problem hasn't caused serious symptoms like collapsing. We don't have much information about the best treatment for this particular group of patients. The study compares two main treatment options: implanting a small device called a defibrillator, or undergoing a procedure called radiofrequency ablation. Researchers want to see which treatment works best to reduce future heart rhythm problems and improve quality of life. They are also looking at potential side effects and the overall cost-effectiveness of each approach.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

268

Start

12 Jun 2024

Estimated completion

31 Dec 2029

Ischemic Heart Disease Ventricular Tachycardia

What is this study about?

If you have heart disease, you might experience an irregular heartbeat called ventricular tachycardia (VT). This happens when the lower chambers of your heart beat too fast. Sometimes, this can be very serious, but in other cases, people can tolerate it quite well without severe symptoms like fainting or cardiac arrest (where the heart stops pumping).

Doctors are trying to understand the best way to treat VT, especially in people who have heart disease but their heart muscle function (called ejection fraction) is still reasonably good. For many years, an implanted defibrillator was often recommended, which is a small device placed under the skin that can deliver an electric shock to correct a fast heart rhythm. However, for people whose VT is well-tolerated and whose heart function isn't severely impaired, it's not clear if a defibrillator is always the best option. Another treatment is called radiofrequency ablation. This procedure uses heat to create tiny scars in the heart tissue where the abnormal signals are coming from, blocking the faulty electrical pathways.

This study aims to compare these two treatments – implanting a defibrillator versus radiofrequency ablation – in this specific group of patients. We want to find out if ablation might be a better or equally effective treatment, potentially avoiding the need for an implanted device in some cases. The goal is to improve how patients live with their condition and prevent serious problems, while also looking at the impact on their quality of life and the healthcare system.

Key takeaways

Compares two treatments: implanted defibrillator vs. ablation.
For specific heart rhythm problems in heart disease.
Focuses on people with good heart function and well-tolerated symptoms.
Aims to find the best way to improve patient outcomes.
Participation includes regular check-ups and questionnaires.
Random assignment means you don't choose your treatment.

Who may be eligible?

This study is looking for adults between 18 and 90 years old who have a specific type of heart problem.

You might be able to take part if you have certain heart conditions, specifically heart disease due to a past heart attack, and your heart's pumping ability is still quite good. You must also have 'ventricular tachycardia' (a fast heart rhythm) that you tolerate well, meaning it hasn't caused you to faint or your heart to stop. You'll need to be in a position to agree to take part after understanding all the information.

You won't be able to join if your fast heart rhythm has a simple, temporary cause, or if you've had a heart attack very recently (within the last two months). Also, you can't be pregnant, or have other serious health problems that mean it wouldn't be safe for you to have either of the treatments being studied, or if your life expectancy is very short (less than a year).

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.

Do I have heart disease from a past heart attack?
Is my heart's pumping ability (ejection fraction) still pretty good?
Do I have a fast heart rhythm (ventricular tachycardia) that hasn't caused me to faint or have a cardiac arrest?
Am I between 18 and 90 years old?
Am I currently pregnant or considering getting pregnant?
Have I had a heart attack in the last two months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to either receive an implanted defibrillator or undergo a radiofrequency ablation procedure. The choice of treatment will be decided randomly, like flipping a coin, so neither you nor your doctor can choose which one you receive. You'll have regular check-ups to monitor your heart and overall health. We'll also ask you to complete questionnaires about your quality of life, which will help us understand how the treatments affect your daily living. Researchers will collect information about any health issues or side effects you experience during the study. The total duration of your participation will depend on the follow-up schedule set by the study, but typically involves several visits over time to track your progress.

Potential risks and benefits

Taking part in this study could offer you a chance to receive one of two established treatments for your heart condition, and help doctors understand the best care for people like you in the future. However, there are potential risks with both implanted devices and ablation procedures, including bleeding, infection, or other complications. You will be monitored closely for any adverse effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Rangueil Hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is ventricular tachycardia?

It's a type of fast, abnormal heart rhythm that starts in the lower chambers of the heart.

What does 'minimally impaired ejection fraction' mean?

It means your heart muscle's ability to pump blood is still quite good, not severely weakened.

What is a defibrillator?

It's a small device implanted under the skin that can deliver an electric shock if your heart beats too fast.

What is radiofrequency ablation?

It's a procedure that uses heat to carefully scar tiny areas in your heart to block faulty electrical signals causing the fast rhythm.

Will I get to choose my treatment?

No, the treatment you receive will be chosen randomly by the study, like drawing lots.

How to find out more

Philippe MAURY, MD

maury.p@chu-toulouse.fr 5 61 34 10 18 Official trial record

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