Radiotherapy; ComplicationsSABRE-VTNCT05696522
Stereotactic Ablative Radiotherapy for the Treatment of Refractory Ventricular Tachycardia
A study testing Stereotactic ablative radiotherapy in people with Radiotherapy; Complications and Ventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Ventricular tachycardia (VT) is an abnormal rhythm arising from the bottom chambers (ventricles) of the heart. The hearts of most patients who develop VT have been previously damaged by a myocardial infarction (heart attack) or other heart muscle diseases (cardiomyopathies). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Radiotherapy; Complications, Ventricular Tachycardia, Structural Heart Abnormality
- What is being tested?
- Stereotactic ablative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2023to 2 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They are at least 18-85 years old.
- They have recurrent VT (at least three episodes in the preceding six months) requiring therapy from an ICD, that is refractory to conventional treatments - both maximally tolerated doses of anti- arrhythmic drugs and/or conventional catheter ablation.
- They are too frail or do not wish to undergo conventional catheter ablation.
- They have not had previous radiotherapy to the anticipated treatment field.
Who cannot join
- They have polymorphic VT or ventricular fibrillation (VF).
- They have inotrope-dependent heart failure or a left ventricular assist device (LVAD) in situ.
- They are unlikely to live more than 12 months irrespective of the VT.
- There is a potentially reversible cause for the VT e.g. critical coronary artery disease or a metabolic problem such as an overactive thyroid gland.
- They are unable to provide informed consent.
- They have had previous radiotherapy to the anticipated treatment field.
- The patient weighs in excess of 170kg (maximum weight capacity of the tables in the imaging department).
Trial locations and contacts
1 site in 1 country.
About this study
Ventricular tachycardia (VT) is an abnormal rhythm arising from the bottom chambers (ventricles) of the heart. The hearts of most patients who develop VT have been previously damaged by a myocardial infarction (heart attack) or other heart muscle diseases (cardiomyopathies). The damage produces scar or fatty deposits that conduct electrical impulses slowly allowing VT to occur. Recurrent episodes of VT can compromise heart function and increase mortality.
VT is prevented by special drugs but these are not always effective and can have many side effects. Most patients with VT will also have a specialised device called an implantable defibrillator (ICD) implanted. The ICD treats VT by either stimulating the heart rapidly or delivering a shock to it. ICDs are very effective but the shocks are painful and have a big impact on quality of life. If VT occurs despite optimal drug treatment, patients undergo an invasive procedure called catheter ablation. Here, wires are passed into the heart from the blood vessels in the leg and the damaged heart muscle causing the VT is identified whilst the heart is in VT. An electrical current is passed down the wire making its tip heat up allowing discrete burns (ablation) to be placed inside the heart. The ablated heart muscle doesn't conduct electricity which stops the VT and prevents it recurring.
Read more
Some patients are so frail that ablation cannot be performed safely. A recent clinical trial has shown that VT can be treated in such patients using radiotherapy, which is usually used to treat tumours with high energy radiation. This approach is non-invasive, painless and requires no sedation or anaesthesia.
This study will test whether VT can be successfully treated using stereotactic ablative radiotherapy. This can deliver high dose radiotherapy very precisely, whilst minimising the risk of damage to healthy tissues.
Read the detailed description
Principal objectives:
- To determine the safety and efficacy of stereotactic ablative radiotherapy (SABR) for the treatment of VT refractory to conventional therapies.
Background:
VT is an abnormal heart rhythm arising from either of the bottom chambers of the heart (ventricles). Most patients with VT have scarring or fatty deposits in the heart muscle caused by a previous heart attack or a heart muscle problem called a cardiomyopathy. The abnormal heart muscle conducts electricity slowly allowing VT to occur. Most patients with VT have a device called an implantable defibrillator (ICD) fitted to treat VT. The ICD has wires going into the heart from a small generator that is inserted under the skin below the left collar bone. ICDs stop VT by stimulating the heart rapidly or by shocking the heart which is very painful and can stun the heart temporarily, weakening its pumping function. Patients who experience a lot of VT can have more admissions to hospital, worsening heart failure and a poorer quality of life, as well as a higher risk of dying. Consequently, all patients are treated with drugs to prevent VT but these are not always effective. If VT keeps recurring, many patients undergo an invasive procedure called catheter ablation where wires are passed into the heart from the leg and the part of the ventricles causing the VT identified. A high frequency electrical current is then passed down one of the wires making its tip heat up allowing discrete burns (ablation) to be placed on the culprit area, which stops the VT and prevents it from recurring. Performing catheter ablation in such patients is a high risk procedure and the overall complication rate is between 5 - 15% in experienced centres. Some patients have recurrent VT despite catheter ablation or the VT cannot be ablated because the patient is too frail, or the VT causes a significant fall in the blood pressure resulting in cardiac arrest (heart stops beating).
In the last 6 years, several case reports and series have been published showing that radiotherapy using different types of linear accelerator machines (including the Cyberknife) can successfully and safely ablate VT. Most recently, a prospective, randomised trial (ENCORE-VT) has reported a dramatic reduction in VT following radioablation.
This study will therefore assess our ability to perform stereotactic radioablation for VT at St Bartholomew's Hospital. We will determine procedural success and safety. Patients will be assessed 3, 6 and 12 months after the treatment and their burden of VT determined by checking the ICD.
- Conditions
- Radiotherapy; Complications, Ventricular Tachycardia, Structural Heart Abnormality, Heart Failure
- Being tested
- Stereotactic ablative radiotherapy
- Keywords
- radiotherapy, ventricular tachycardia, heart failure
- Medical subject headings
- Tachycardia, Ventricular, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative radiotherapyRadiation
Stereotactic ablative radiotherapy will be delivered to a volume of ventricular myocardium responsible for the clinical ventricular tachycardia.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Treatment with stereotactic ablative radiotherapy Receives: Radiation: Stereotactic ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life and cardiac complications as assessed by clinical history, SF-36 questionnaire, electrocardiogram and echocardiography.
The number of serious adverse events at three months after treatment. This will be determined as follows:
- Clinical history from and examination of the patients assessing for new chest pains, breathlessness or coughing.
- SF-36 quality of life questionnaire.
- Echocardiography to assess for pericardial effusion that could indicate radiation-induced pericarditis.
- Electrocardiogram to assess for pericarditis or myocarditis caused by radiation.
Measured: 3 months
Efficacy endpoint - Cumulative VT burden 6 months before and 6 months after radiotherapy.
There will be a six week blanking period after radiotherapy to allow for ablation effect. The burden of VT will be assessed by interrogating the patient's ICD and assessing the number of episodes of non-sustained and sustained VT as well as the number of ICD therapies delivered.
Measured: 6 months
Secondary outcomes (7)
VT burden
Cumulative VT burden in the second 6 months following radiotherapy. This will be assessed by ICD interrogation as described above.
Measured: 6 months
Survival
Overall survival at 3, 6 and 12 months following radiotherapy.
Measured: 12 months
Cardiac function changes from radiotherapy
Absolute change in numerical left ventricular ejection fraction assessed with echocardiography, at 3, 6 and 12 months.
Measured: 12 months
Radiotherapy impact on ICD function
Deterioration in implantable cardioverter-defibrillator function attributable to radiotherapy at 3, 6 and 12 months. This will be determined by interrogating the ICD and measuring the change in ICD defibrillator lead impedance.
Measured: 12 months
Quality of life assessment using SF-36 questionnaire
The SF-36 questionnaire will be used at 3, 6 and 12 months to assess this.
Measured: 12 months
Heart failure status using New York Heart Association (NYHA) breathlessness class.
Patients will be assessed at 3, 6 and 12 months by taking a history for breathlessness, scaled I to IV according to their NYHA class.
Measured: 12 months
Cardiac conduction system status measured by ECG QRS duration.
An electrocardiogram will be performed at 3, 6 and 12 months to look for any changes in the QRS complex duration.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start12 Jan 2023
- Primary completion2 May 2025
- Study completion2 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, pilots study with open label, non-randomised design.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696522
- Sponsor's protocol ID
- 262246
- Acronym
- SABRE-VT
- Status last verified
- Sep 2026
- First submitted
- 21 Feb 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Ablative Radiotherapy for the Treatment of Refractory Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05696522
- Acronym / sponsor ID
- SABRE-VT / 262246
- Conditions
- Radiotherapy; Complications, Ventricular Tachycardia, Structural Heart Abnormality, Heart Failure
- Keywords
- radiotherapy, ventricular tachycardia, heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2026 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ventricular tachycardia (VT) is an abnormal rhythm arising from the bottom chambers (ventricles) of the heart. The hearts of most patients who develop VT have been previously damaged by a myocardial infarction (heart attack) or other heart muscle diseases (cardiomyopathies). The damage produces scar or fatty deposits that conduct electrical impulses slowly allowing VT to occur. Recurrent episodes of VT can compromise heart function and increase mortality.
VT is prevented by special drugs but these are not always effective and can have many side effects. Most patients with VT will also have a specialised device called an implantable defibrillator (ICD) implanted. The ICD treats VT by either stimulating the heart rapidly or delivering a shock to it. ICDs are very effective but the shocks are painful and have a big impact on quality of life. If VT occurs despite optimal drug treatment, patients undergo an invasive procedure called catheter ablation. Here, wires are passed into the heart from the blood vessels in the leg and the damaged heart muscle causing the VT is identified whilst the heart is in VT. An electrical current is passed down the wire making its tip heat up allowing discrete burns (ablation) to be placed inside the heart. The ablated heart muscle doesn't conduct electricity which stops the VT and prevents it recurring.
Some patients are so frail that ablation cannot be performed safely. A recent clinical trial has shown that VT can be treated in such patients using radiotherapy, which is usually used to treat tumours with high energy radiation. This approach is non-invasive, painless and requires no sedation or anaesthesia.
This study will test whether VT can be successfully treated using stereotactic ablative radiotherapy. This can deliver high dose radiotherapy very precisely, whilst minimising the risk of damage to healthy tissues.
Detailed description
Principal objectives:
- To determine the safety and efficacy of stereotactic ablative radiotherapy (SABR) for the treatment of VT refractory to conventional therapies.
Background:
VT is an abnormal heart rhythm arising from either of the bottom chambers of the heart (ventricles). Most patients with VT have scarring or fatty deposits in the heart muscle caused by a previous heart attack or a heart muscle problem called a cardiomyopathy. The abnormal heart muscle conducts electricity slowly allowing VT to occur. Most patients with VT have a device called an implantable defibrillator (ICD) fitted to treat VT. The ICD has wires going into the heart from a small generator that is inserted under the skin below the left collar bone. ICDs stop VT by stimulating the heart rapidly or by shocking the heart which is very painful and can stun the heart temporarily, weakening its pumping function. Patients who experience a lot of VT can have more admissions to hospital, worsening heart failure and a poorer quality of life, as well as a higher risk of dying. Consequently, all patients are treated with drugs to prevent VT but these are not always effective. If VT keeps recurring, many patients undergo an invasive procedure called catheter ablation where wires are passed into the heart from the leg and the part of the ventricles causing the VT identified. A high frequency electrical current is then passed down one of the wires making its tip heat up allowing discrete burns (ablation) to be placed on the culprit area, which stops the VT and prevents it from recurring. Performing catheter ablation in such patients is a high risk procedure and the overall complication rate is between 5 - 15% in experienced centres. Some patients have recurrent VT despite catheter ablation or the VT cannot be ablated because the patient is too frail, or the VT causes a significant fall in the blood pressure resulting in cardiac arrest (heart stops beating).
In the last 6 years, several case reports and series have been published showing that radiotherapy using different types of linear accelerator machines (including the Cyberknife) can successfully and safely ablate VT. Most recently, a prospective, randomised trial (ENCORE-VT) has reported a dramatic reduction in VT following radioablation.
This study will therefore assess our ability to perform stereotactic radioablation for VT at St Bartholomew's Hospital. We will determine procedural success and safety. Patients will be assessed 3, 6 and 12 months after the treatment and their burden of VT determined by checking the ICD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, pilots study with open label, non-randomised design.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Radiation: Stereotactic ablative radiotherapyTreatment with stereotactic ablative radiotherapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- They are at least 18-85 years old.
- They have recurrent VT (at least three episodes in the preceding six months) requiring therapy from an ICD, that is refractory to conventional treatments - both maximally tolerated doses of anti- arrhythmic drugs and/or conventional catheter ablation.
- They are too frail or do not wish to undergo conventional catheter ablation.
- They have not had previous radiotherapy to the anticipated treatment field.
Key exclusion criteria (7 listed)
- They have polymorphic VT or ventricular fibrillation (VF).
- They have inotrope-dependent heart failure or a left ventricular assist device (LVAD) in situ.
- They are unlikely to live more than 12 months irrespective of the VT.
- There is a potentially reversible cause for the VT e.g. critical coronary artery disease or a metabolic problem such as an overactive thyroid gland.
- They are unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic ablative radiotherapyStereotactic ablative radiotherapy will be delivered to a volume of ventricular myocardium responsible for the clinical ventricular tachycardia. | Radiation | Treatment arm |
Primary outcome
Change in quality of life and cardiac complications as assessed by clinical history, SF-36 questionnaire, electrocardiogram and echocardiography.
Time frame: 3 months
The number of serious adverse events at three months after treatment. This will be determined as follows: 1. Clinical history from and examination of the patients assessing for new chest pains, breathlessness or coughing. 2. SF-36 quality of life questionnaire. 3. Echocardiography to assess for pericardial effusion that could indicate radiation-induced pericarditis. 4. Electrocardiogram to assess for pericarditis or myocarditis caused by radiation.
Efficacy endpoint - Cumulative VT burden 6 months before and 6 months after radiotherapy.
Time frame: 6 months
There will be a six week blanking period after radiotherapy to allow for ablation effect. The burden of VT will be assessed by interrogating the patient's ICD and assessing the number of episodes of non-sustained and sustained VT as well as the number of ICD therapies delivered.
7 secondary outcomes
VT burden
Time frame: 6 months
Survival
Time frame: 12 months
Cardiac function changes from radiotherapy
Time frame: 12 months
Radiotherapy impact on ICD function
Time frame: 12 months
Quality of life assessment using SF-36 questionnaire
Time frame: 12 months
Heart failure status using New York Heart Association (NYHA) breathlessness class.
Time frame: 12 months
Cardiac conduction system status measured by ECG QRS duration.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic ablative radiotherapy in people with Radiotherapy; Complications and Ventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life and cardiac complications as assessed by clinical history, SF-36 questionnaire, electrocardiogram and echocardiography. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.