RecruitingPHASE3INTERVENTIONAL

Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial

This study is looking at two ways to treat a specific type of irregular and fast heartbeat called Ventricular Tachycardia, or VT. The first way, called catheter ablation, is the standard treatment available now. It involves guiding thin tubes into your heart to fix the problem. The second way, called non-invasive radio-ablation, is a new approach that uses targeted radiation, similar to treatment for some cancers, to correct the heart rhythm without needing surgery. We want to see if this new non-invasive method works as well as, or better than, the current standard treatment. This research could lead to a less invasive and potentially safer option for people with VT.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

244

Start

06 Dec 2022

Estimated completion

15 Dec 2027

Ventricular Tachycardia

What is this study about?

This study is about finding the best way to treat a serious heart condition called Ventricular Tachycardia (VT). If you have VT, it means your heart beats very fast and irregularly, which can be dangerous.

Currently, there are several ways to manage VT, including medicines and a device called an ICD (Implantable Cardioverter Defibrillator) which can give your heart an electric shock if it goes out of rhythm. Another common treatment is catheter ablation. This procedure involves doctors inserting thin tubes into your blood vessels, guiding them to your heart, and using energy to fix the areas causing the irregular beats. While effective, catheter ablation can be a long procedure and carries some risks, especially for people who are already quite unwell.

This study compares the standard catheter ablation with a new, less invasive treatment called non-invasive radio-ablation. Instead of inserting tubes into your heart, this new method uses very precise radiation, similar to how some cancers are treated, to target and fix the problem areas in your heart. We're using a special scanning technology to help us pinpoint exactly where the problem is. The goal is to see if this new non-invasive treatment can be as effective as catheter ablation, but with fewer risks and a shorter recovery time, improving care for people with VT.

Key takeaways

Compares two VT treatments: standard catheter ablation vs. new radio-ablation.
Aims to find a less invasive and potentially safer VT treatment.
Specifically for people aged 55+ with VT, heart weakness, and an ICD.
Participation involves tests, treatment, and follow-up appointments.
You will be randomly assigned to one of the two treatments.
You can stop participating at any time.

Who may be eligible?

This study is looking for people aged 55 or older who have a specific heart condition called Ventricular Tachycardia (VT). You would also need to have weakening of your heart muscle (cardiomyopathy) and an ICD device already fitted.

Additionally, you should be experiencing VT events even after having a previous catheter ablation, or your VT events need treatment and you meet certain health criteria. You cannot take part if you have very severe heart failure, are not expected to live more than a year due to other health problems, or have had radiation therapy to your chest before. We also can't include you if you're taking part in another clinical trial.

For women, you cannot be pregnant or breastfeeding. If you are of childbearing age, you would need to agree to use effective birth control throughout the study to ensure your safety and the accuracy of the trial.

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 55 years old or older?
Do you have Ventricular Tachycardia (VT)?
Do you have a weakened heart muscle (cardiomyopathy) and an ICD device already implanted?
Have you had VT events even after a previous catheter ablation, OR do your VT events require treatment and meet specific health criteria?
Are you able and willing to give your informed consent to participate?
Are you not currently pregnant or breastfeeding (for women)?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would be randomly assigned to receive either the standard catheter ablation treatment or the new non-invasive radio-ablation. You would have several appointments for tests and scans to help doctors understand your heart condition and plan your treatment. These might include heart scans like echocardiograms, CT scans, and PET scans.

If you receive catheter ablation, it's a procedure typically done under sedation or general anaesthetic, using thin tubes inserted into your heart via your groin. If you receive non-invasive radio-ablation, it involves a session of targeted radiation without the need for these tubes. After your treatment, you would have follow-up appointments to check how you are recovering and how your heart rhythm is doing. The total time you'd be involved in the study, including all evaluations and follow-ups, would be discussed with you.

Potential risks and benefits

Participating in this study might offer you the chance to receive a new, potentially less invasive treatment for your Ventricular Tachycardia, which could lead to a quicker recovery. However, like all medical procedures, both catheter ablation and radio-ablation carry potential risks, which your doctor will explain in detail. There might also be risks associated with the extra tests and visits. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is Ventricular Tachycardia (VT)?

VT is a type of irregular and very fast heartbeat that starts in the lower chambers of your heart. It can be serious and needs treatment.

What is the difference between the two treatments in this study?

Catheter ablation is the standard treatment where doctors use thin tubes to fix heart rhythm problems. Radio-ablation is a new approach that uses targeted radiation, like X-rays, to achieve the same result without surgery.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two treatments, like flipping a coin. This helps us fairly compare the two methods.

What if I change my mind after joining the study?

You can leave the study at any time, for any reason, and it won't affect your medical care.

Are there any side effects from the treatments?

Both treatments have potential side effects and risks, which your medical team will explain to you thoroughly before you decide to join.

How to find out more

Calum Redpath

credpath@ottawaheart.ca 6136967000 Official trial record

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