Not yet recruitingNAINTERVENTIONAL

Stereotactic Radioablation as First-Line Therapy for Scar-Related Ventricular Tachycardia

This study is looking at a new treatment called Stereotactic Arrhythmia Radioablation (STAR) for a serious condition called ventricular tachycardia (VT). VT is a dangerously fast heartbeat often caused by scar tissue in the heart, common after a heart attack. People with VT usually have a device (ICD) to prevent sudden death, but they can still get painful shocks. Current treatments have their drawbacks. STAR uses a single, precise dose of radiation to target the heart scar. This study will give STAR as a first treatment to 20 adults with VT and heart disease. Researchers will follow them for a year to check if STAR reduces VT and is safe, hoping it's as good as existing treatments but with fewer invasiveness concerns.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Southlake Health

Enrolment target

Start

01 Jul 2026

Estimated completion

01 Jul 2029

Ventricular Tachycardia, Monomorphic Cardiomyopathies

What is this study about?

Imagine your heart has an electrical glitch, causing it to beat dangerously fast and irregularly. This is called Ventricular Tachycardia (VT), and it's often due to scar tissue in the heart, perhaps from a past heart attack or another heart condition. While many people with VT have a device called an Implantable Cardioverter-Defibrillator (ICD) to deliver a shock and reset the heart if it beats too fast, these shocks can be painful and upsetting, and don't stop the VT from happening again.

Currently, doctors use medicines or a procedure called catheter ablation (where a long tube is inserted into the heart to burn away the problem area) to try and stop VT. However, these treatments don't always work perfectly, can have side effects, or may be too risky for some people. This new study is exploring a treatment called Stereotactic Arrhythmia Radioablation (STAR).

STAR is a bit like precise radiotherapy used for other conditions. It's a non-invasive treatment where a single, carefully aimed beam of radiation is directed at the exact part of the heart scar that's causing the fast heartbeat. The aim is to calm down or stop that problematic area. Previous studies have shown promising results in people who couldn't have or didn't respond to other treatments. This study wants to see if STAR can be a good, safe, and effective first treatment option for people newly diagnosed with this type of VT.

Key takeaways

This study is testing a non-invasive radiation treatment (STAR) for fast heartbeats (VT).
It aims to see if STAR can be an effective first treatment, reducing painful defibrillator shocks.
STAR precisely targets scar tissue in the heart causing the problem.
Participation involves one treatment and follow-up visits over one year.
Potential benefits include fewer fast heartbeats; risks include possible treatment-related side effects.
You can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have heart disease with scar tissue in their heart muscle. You must also have experienced persistent fast heartbeats (ventricular tachycardia) in the last six months, whether you felt them or your defibrillator gave you a shock.

There are also reasons why you might not be able to join. For example, if your fast heartbeat is caused by something temporary, like certain medications or an imbalance in your body, or if you've recently had a heart attack or heart surgery. You also can't participate if you've had high-dose radiation to your chest before, need radiation for cancer, or if the specific area causing your fast heartbeat can't be safely targeted with this type of treatment. Lastly, if you can't lie still for the treatment, are pregnant or breastfeeding, or are being considered for a heart transplant, you won't be able to join.

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 heart disease with scarring in your heart muscle?
Have you experienced persistent fast heartbeats (VT) in the last 6 months?
Have you NOT had a recent heart attack or heart surgery (within 3 months)?
Are you NOT currently pregnant or breastfeeding?
Can you lie still during a medical procedure?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single, carefully targeted radiation treatment (STAR) to the problematic area of your heart. Before the treatment, doctors will use special scans to pinpoint the exact location. After your treatment, you'll have follow-up visits with the study team at around 6 weeks, then 3, 6, 9, and 12 months. During these visits, doctors will check your progress, how often your heart beats fast, if you've had any defibrillator shocks, and make sure you're feeling well and haven't had any unexpected side effects. The total monitoring period for the study is one year.

Potential risks and benefits

The potential benefit of taking part is that STAR could offer a new, non-invasive way to reduce your fast heartbeats and potentially decrease the number of painful defibrillator shocks, which could improve your quality of life. However, as with any medical treatment, there are potential risks. These include a possible worsening of heart failure, a drop in how well your heart pumps, or specific side effects related to the radiation, such as inflammation of the lungs (pneumonitis), throat (esophagitis), or the sac around your heart (pericarditis). These side effects will be carefully monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Southlake Regional Health Centre
Verified postcode
Newmarket, Canada

Common questions

What is ventricular tachycardia (VT)?

VT is a serious type of fast, abnormal heartbeat that starts in the lower chambers of your heart, often in scarred areas.

What is STAR treatment?

STAR (Stereotactic Arrhythmia Radioablation) uses a single, very precise beam of radiation to target and treat the specific scar tissue in your heart causing the fast heartbeats.

Is STAR a new treatment?

While STAR has been used successfully in some patients who couldn't have other treatments, this study is testing if it can be a good first treatment for VT.

Will I still need my ICD (defibrillator) if I have STAR?

Yes, your ICD is very important for your safety and will remain in place to protect you if needed, even after STAR treatment.

How long will I be involved in the study?

You'll have one treatment session, then follow-up appointments over a period of one year to monitor your progress and safety.

How to find out more

Mouhannad Sadek, MD

msadek@southlake.ca 905-895-4521 Official trial record

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