RecruitingNAINTERVENTIONAL

Cohort Study - SBRT for VT Radioablation

This study explores a potential new treatment for a serious heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, like an electrical 'short circuit', and is a major cause of sudden heart death. Current treatments include pacemakers (ICDs), medicines, or a procedure called catheter ablation, but these don't always work for everyone. This study uses a specialised type of radiation treatment, called Stereotactic Body Radiotherapy (SBRT), to target and fix the affected part of the heart. SBRT is usually used for cancer and involves delivering highly focused radiation to a specific area. The aim is to see if this non-invasive approach can safely reduce or stop VT in patients who haven't had success with other treatments.

At a glance

Status

Recruiting

Phase

Sponsor

John Sapp

Enrolment target

Start

01 Jun 2021

Estimated completion

01 Sep 2027

Ventricular Tachycardia Myocardial Infarction Heart Disease Structural Disorder

What is this study about?

Imagine your heart as an electrical system. Sometimes, a 'short circuit' can happen, causing it to beat very fast and irregularly. This is called ventricular tachycardia (VT), and it can be very serious, sometimes leading to sudden death. While there are treatments like implanted devices (ICDs), medications, or a procedure called catheter ablation (where doctors try to fix the short circuit from inside the heart), these don't always work for everyone. For some, the VT keeps coming back, even after several attempts at treatment. When this happens, it can be quite distressing and impact a person's quality of life, especially if they're experiencing frequent shocks from their ICD.

This study is investigating a new, non-surgical approach for people who haven't responded well to these standard treatments. It uses a technique called Stereotactic Body Radiotherapy (SBRT). Think of SBRT as a very precise way of delivering a high dose of radiation. Doctors normally use this method to treat cancers, carefully aiming the radiation at the tumour while protecting nearby healthy tissues. However, in this study, doctors are exploring if they can use this same precision to target and 'fix' the small area in the heart that's causing the VT short circuit.

Researchers want to see if this targeted radiation can safely and effectively stop the VT in these patients. It's a hopeful step towards offering a new option for individuals who have tried other treatments without success. This study will carefully observe how a small group of patients respond to SBRT, tracking their heart rhythm and overall well-being over time.

Key takeaways

This study explores a new non-surgical treatment for certain severe heart rhythm problems (VT).
It uses targeted radiation (SBRT) to fix 'short circuits' in the heart.
It's for patients whose VT hasn't improved with standard treatments.
The treatment itself is a single, relatively short session.
Follow-up involves regular check-ups to monitor heart rhythm.
It may offer a new hope for those with difficult-to-treat VT.

Who may be eligible?

This study is looking for a specific group of patients. To be considered, you must have a heart condition that has led to damage or scarring in your heart muscle. On top of this, you need to have experienced ongoing ventricular tachycardia (VT) that hasn't improved with typical treatments.

This means you would have tried catheter ablation (a procedure to correct heart rhythm problems) but it didn't work or wasn't suitable for you. You would also have tried antiarrhythmic medications, but they either weren't effective, you couldn't tolerate them due to side effects, or they weren't safe for you to take. The VT you've experienced would also need to be confirmed by medical records.

There are also reasons why you might not be able to join the study. For example, if you've had radiation to your chest area before, if you are very unwell with heart failure, if you are pregnant, or if your VT is caused by a different type of heart problem or something that can be easily fixed, you likely wouldn't be eligible. The medical team will carefully review your history to see if this study is right for you.

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 you have heart damage or scarring?
Has your VT continued despite trying catheter ablation or medication?
Have you had your VT confirmed by medical tests?
Have you NOT had previous radiation treatment to your chest area?
Are you able to provide informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of 12 patients taking part. First, the medical team will gather all your existing heart scan results, medical history, and information from any previous heart procedures. You'll then have further detailed heart scans, which might include special CT and MRI scans. These scans, along with information from your previous procedures, will help the team create a very precise treatment plan, identifying the exact area in your heart that needs treatment.

The SBRT treatment itself is given using a special machine, and the actual radiation delivery takes about 30 minutes. After your treatment, you'll have follow-up appointments at 6 weeks, 12 weeks, 7.5 months, and then every 6 months. During these visits, doctors will check how well the treatment is working and look at information from your implanted defibrillator (if you have one). There won't be any new scans or detailed heart mapping during these follow-up visits. You'll be followed for at least 7.5 months, and up to 2 years, depending on when you start the study.

Potential risks and benefits

Participating in this study offers the potential benefit of a new, non-invasive treatment for persistent ventricular tachycardia (VT) that hasn't responded to other therapies. This could lead to fewer VT episodes and potentially reduce the number of shocks from an implanted defibrillator, improving your quality of life. However, like any medical procedure, there are potential risks associated with SBRT, including the effects of radiation on surrounding heart tissue or other organs. The detailed imaging required also carries small risks, and the radiation treatment itself will be discussed thoroughly with you. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Nova Scotia Health Authority
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is ventricular tachycardia (VT)?

VT is a serious condition where the heart beats very rapidly due to a 'short circuit' in its electrical system, which can be life-threatening.

What is SBRT?

SBRT is a highly focused type of radiation treatment, usually used for cancer, that precisely targets a specific area while protecting surrounding healthy tissue.

Is this a new treatment for VT?

Yes, using SBRT for VT is a relatively new approach, mainly for patients whose VT hasn't been controlled by standard treatments.

Will I receive radiation to my whole body?

No, SBRT is designed to deliver radiation very precisely to a small, targeted area within your heart, not to your whole body.

What happens if I stop participating?

You are free to leave the study at any time without it affecting the standard medical care you receive for your heart condition.

How to find out more

Karen Giddens

karen.giddensl@nshealth.ca 902 237-5551 Official trial record

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