RecruitingNAINTERVENTIONAL

Stereotactic Ablative Radiotherapy for the Treatment of Refractory Ventricular Tachycardia

This study is investigating a new treatment for a serious heart condition called ventricular tachycardia (VT). VT is a very fast and abnormal heartbeat that can make you feel unwell and is often treated with medication or a procedure called catheter ablation. However, some people are too unwell for these treatments, or they don't work. This study is testing a type of radiation therapy, called stereotactic ablative radiotherapy, which is usually used for cancer. This radiation delivers a very precise dose to a small area. We want to see if this treatment can safely and effectively stop VT in people who haven't responded to other treatments or can't have them. It's a non-invasive treatment, meaning it doesn't involve surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Barts & The London NHS Trust

Enrolment target

Start

12 Jan 2023

Estimated completion

02 May 2026

Radiotherapy; Complications Ventricular Tachycardia Structural Heart Abnormality Heart Failure

What is this study about?

You're probably reading this because you, or someone you know, has a condition called ventricular tachycardia (VT). This is a type of abnormal heartbeat where the bottom chambers of your heart beat too quickly. This often happens if your heart has been damaged in the past, perhaps by a heart attack or another heart muscle problem, leaving behind scars that can make your heart's electrical system go haywire. When VT happens often, it can make you feel very tired, weak, and can sometimes be dangerous. Many people with VT have a special device called an ICD fitted, which can give a shock to reset the heart, but these shocks can be painful and upsetting.

Usually, doctors try to control VT with medicines or a procedure called catheter ablation. In ablation, doctors guide thin wires into your heart through blood vessels in your leg. They then use heat to create tiny scars to block the faulty electrical signals causing the VT. However, not everyone can have ablation, sometimes because they are too unwell or frail for the procedure, or in some cases, it doesn't completely stop the VT. This is where this study comes in.

We're exploring a new approach using a treatment called stereotactic ablative radiotherapy (SABR). This is a type of radiation therapy, usually used for treating cancers, that delivers a very focused and high dose of radiation precisely to a small area. The idea is that this focused radiation could create similar tiny scars in the heart that ablation does, but without the need for an invasive procedure. This study aims to check how safe and effective SABR is at stopping VT in people who haven't been helped by or can't have the usual treatments.

Key takeaways

This study explores a new, non-surgical treatment for persistent VT.
It uses a precise radiation therapy (SABR) usually for cancer, to treat the heart.
It's for people whose VT hasn't responded to other treatments or who can't have them.
The aim is to reduce painful ICD shocks and improve quality of life.
Participation involves scans, a single radiation treatment, and follow-up appointments.
It's an important step in finding better ways to manage difficult-to-treat VT.

Who may be eligible?

To be considered for this study, you would typically be between 18 and 85 years old. The main requirement is that you have ongoing VT that your ICD has had to treat at least three times in the last six months, and that other treatments like strong medications haven't worked or you've already had catheter ablation but the VT has returned. It's also for people who are physically too unwell or choose not to have a catheter ablation.

There are also some reasons why you might not be able to join. For example, if you have a different type of very fast heartbeat called polymorphic VT, or if your heart failure is very severe and requires special heart support devices. We also can't include you if you've already had radiation treatment to the area where your heart is, if there's a simple, fixable cause for your VT (like a blocked blood vessel in your heart or a thyroid problem), or if doctors believe you wouldn't live for more than another year, regardless of your VT. Finally, you must be able to understand and agree to take part in the study and weigh less than 170kg.

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 between 18 and 85 years old?
Has your ICD treated your VT at least 3 times in the last 6 months, despite other treatments?
Are you unable or unwilling to have a catheter ablation procedure?
Have you NOT had previous radiation treatment to your chest/heart?
Do you weigh less than 170kg (about 26 stone)?
Can you understand information about the study and agree to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive stereotactic ablative radiotherapy. This is an outpatient treatment, meaning you won't usually need to stay in hospital overnight. Before the treatment, you will undergo several scans, including special CT and MRI scans, and possibly a PET scan, to help the medical team precisely plan where to deliver the radiation. You will also have appointments to discuss the treatment and your progress.

The radiotherapy itself is non-invasive and painless. You will lie still while the machine delivers the radiation, similar to having an X-ray, but for a longer time. Most participants will only need one treatment session. After the treatment, you will have regular follow-up appointments, including check-ups with the study doctors and nurses, and scans of your heart to monitor your VT and overall health. The total duration of follow-up will vary but will involve regular checks for at least a year or more.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as a new way to treat your VT if other options haven't worked or aren't suitable for you. This treatment is non-invasive and aims to reduce painful ICD shocks and improve your quality of life. However, there are also potential risks; although the radiation is precisely targeted, there's a small chance it could affect surrounding healthy tissues, like parts of your lungs, gullet, or other areas of your heart, leading to side effects. The long-term effects of this type of radiation on the heart are still being studied. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is ventricular tachycardia (VT)?

VT is an abnormally fast and irregular heart rhythm coming from the bottom chambers of your heart. It can make you feel dizzy or faint.

What is stereotactic ablative radiotherapy (SABR)?

It's a very precise type of radiation treatment, usually used for cancer, that delivers a high dose to a small, specific area without surgery.

Is this a new treatment for VT?

Yes, it's a newer approach being tested for VT, especially for people who haven't had success with standard treatments or can't undergo them.

Will I need surgery for this treatment?

No, this treatment is non-invasive, meaning it doesn't involve any cuts or surgery.

How long does the treatment take?

The actual radiation treatment usually involves just one session, though planning and follow-up take longer.

How to find out more

Hakam Abbas, MSc

Hakam.abbass@nhs.net 020 37658635 Official trial record

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