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Enrolling by invitationPHASE2INTERVENTIONAL

Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)

This study is investigating a new radiation treatment called stereotactic body radiotherapy (SBRT) for people with ventricular tachycardia (VT), a serious heart rhythm issue. VT can cause the heart to beat dangerously fast and often doesn't respond well to usual treatments. Previous small studies have shown that SBRT can effectively reduce VT episodes. This trial aims to further understand how well this treatment works and to find the lowest effective dose (20 Gy in one session). The goal is to get the same good results as before but with even less radiation exposure, making it safer for healthy heart tissue. This treatment is minimally invasive, meaning it doesn't involve surgery, and could offer a new option for patients whose VT has been hard to control.

At a glance

Status
Enrolling by invitation
Phase
PHASE2
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrolment target
9
Start
01 Jul 2023
Estimated completion
31 Dec 2031

What is this study about?

Imagine your heart as an electrical system. Sometimes, a fault in this system can cause your heart to beat very fast and irregularly. This is called ventricular tachycardia, or VT. For some people, VT can be life-threatening and doesn't respond well to usual treatments like medicines or a procedure called catheter ablation.

Recently, doctors have been exploring a new approach using a very precise type of radiation therapy, similar to that used for some cancers. This treatment, called stereotactic body radiotherapy (SBRT), aims a focused beam of radiation at the specific areas in the heart where the VT starts. Early studies in people with VT that was difficult to treat have shown promising results, with patients having fewer VT episodes and feeling better.

This specific study, called StAR-VT, is following up on these early successes. Researchers want to understand if they can use a slightly lower dose of radiation (20 Gy in a single treatment) and still get the same good results as higher doses tried before. The main reason for this is to reduce any potential side effects from the radiation and protect the healthy parts of the heart as much as possible, while still effectively treating the VT. It's a way to fine-tune this new treatment to make it as safe and effective as possible for future patients.

Key takeaways

  • The study explores a new radiation treatment (SBRT) for difficult-to-treat VT.
  • It aims to find the lowest effective dose to reduce side effects.
  • Early results have shown promise in reducing VT episodes.
  • The treatment is non-surgical and involves a single session.
  • It's for people whose VT hasn't responded to standard treatments.

Who may be eligible?

To be considered for this study, you generally need to be at least 18 years old and have a specific type of heart problem called cardiomyopathy (either from heart disease or another cause).

Crucially, you must have experienced repeated episodes of an irregular heartbeat called monomorphic ventricular tachycardia (VT) that haven't responded well to standard treatments, including at least one antiarrhythmic medicine. You should also have had a previous procedure to map out and treat your heart's electrical system (called an electrophysiology study and ablation).

There are also some reasons why you might not be able to join. For example, if you've already had radiation treatment in the same area of your chest, have certain ongoing health conditions like active connective tissue disease or lung scarring, or if you are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.

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.

  1. Are you at least 18 years old?
  2. Do you have a heart condition called cardiomyopathy?
  3. Has your VT continued even after trying medicines and/or a previous heart procedure (ablation)?
  4. Are you able to have heart mapping procedures?
  5. Are you currently not pregnant or breastfeeding, and not planning to be during the study?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single treatment session of stereotactic body radiotherapy (SBRT). Before this, there will be assessments to carefully map the area of your heart causing the VT. After the treatment, you'll have regular follow-up appointments and tests to check how you're doing, whether the treatment has been effective in reducing your VT, and to monitor for any side effects. These follow-up visits will likely involve heart rhythm monitoring and doctor consultations. The full duration of your participation in the study, including all follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in this study may offer the potential benefit of reducing your ventricular tachycardia (VT) episodes and improving your quality of life, especially if other treatments haven't worked well for you. However, as with any medical treatment, there are potential risks associated with radiation therapy, such as temporary side effects like tiredness or skin changes, or more serious but rare effects on nearby organs. The study aims to minimise these risks by using a lower radiation dose. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Cedars Cancer Center, McGill University Health Centre
    Verified postcode
    Montreal, Canada

Common questions

What is ventricular tachycardia (VT)?

VT is a type of irregular heartbeat where the lower chambers of your heart beat very fast, which can be dangerous.

What is this new treatment, SBRT?

SBRT is a highly focused type of radiation treatment that targets the specific area in your heart causing the VT, without needing surgery.

How many treatments will I receive?

The study involves a single treatment session of radiation therapy.

Will this treatment completely cure my VT?

While promising, the goal of this study is to reduce VT episodes and improve quality of life. It's not guaranteed to be a complete cure.

Is radiation treatment safe for my heart?

The study aims to use a very precise and lower dose of radiation to protect healthy heart tissue, but like all treatments, there are potential risks which the doctors will discuss with you.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Stereotactic Arrhythmia Radioablation for Ventricular Tachyc…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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