Ventricular TachycardiaRadioAblate-VTNCT06360939
Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
A study testing SBRT and CA in people with Ventricular Tachycardia and Cardiomyopathies, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Cardiomyopathies, Arrhythmias, Cardiac
- What is being tested?
- SBRT and CA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Nov 2025to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of
- segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
- myocardial hypertrophy
- myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
- Recurrent monomorphic VT which can include
- at least one episode of VT treated by ICD and/or
Show all 9Show fewer
- sustained VT (lasting >30s) and/or
- inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
- PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.
Who cannot join
- Age < 18 years
- Life expectancy < 3 months
- Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
- Unwilling or unable to provide consent
- Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
- Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital
Westmead
A/Prof Kumar, 02 8890 8140, saurabh.kumar@health.nsw.gov.au
Saurabh Kumar
About this study
The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:
- What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months
- What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).
Read the detailed description
Hypothesis
We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events.
Aims
This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in:
- An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention
- Comparable safety profile (serious adverse events [SAE] and adverse events of special interest [AESI] at 6 months;
- reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).
- Being tested
- SBRT, CA
- Keywords
- catheter ablation, stereotactic body radiation therapy, non invasive, radioablation
- Medical subject headings
- Tachycardia, Ventricular, Cardiomyopathies, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization
CAProcedure or surgery
CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | SBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging. Receives: Radiation: SBRT |
| Catheter ablation | Active comparator | CA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease) Receives: Procedure: CA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT burden
Change in proportion of patients with a ≥75% reduction in VT burden at 6 months (number of VT episodes in 6 months post treatment compared to the number of VT episodes in the 6 months prior to randomisation excluding a 6-week blanking period after treatment initiation)
Measured: 6 months
Secondary outcomes (13)
Recurrent sustained VT
Recurrent sustained VT ascertained by implanted cardioverter defibrillator (ICD) (VT identified and treated by the ICD with anti-tachycardia pacing (ATP) and/or internal ICD delivered shock or ≥30 seconds of VT if untreated by ICD
Measured: 6, 12, 24 and 36 months
VT storm
VT storm (three or more documented episodes of VT within 24 hours or incessant VT)
Measured: 6, 12, 24 and 36 months
Absolute VT burden
Absolute percentage reduction in VT burden compared to pre-ablation
Measured: 6, 12, 24 and 36 months
Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)
- SAE and AESI related to effects of SBRT
- SAE and AESI related to standard care e.g. medical anti-arrhythmic drug therapy or catheter ablation or heart transplantation
Measured: At all time points up to 36 months
ICD shocks
Implantable Cardioverter Defibrillator shocks
Measured: 6, 12, 24 and 36 months
Hospitalization
Cardiovascular as well as specifically heart failure and arrhythmia
Measured: 6, 12, 24 and 36 months
All cause mortality
All cause mortality
Measured: 6,12, 24 and 36 months
Cardiovascular Mortality
Cardiovascular mortality
Measured: 6,12, 24 and 36 months
Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation
Composite outcome as above
Measured: 6,12, 24 and 36 months
Ventricular function
As determined by echocardiography (ejection fraction, speckle tracking echocardiography)
Measured: 6,12, 24 and 36 months
Quality of Life as per Short Form - 36 (SF-36) Score
Change in quality of life at 6 and 12 months (compared to pre-intervention) as measured by Short Form- 36 (SF-36) [0-100 scale, 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability].
Measured: 6,12, 24 and 36 months
Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score
Change in quality of life at 6 and 12 months (compared to pre-intervention) as measured by Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score. [0-100 scale, 100 equivalent to maximum concern]
Measured: 6,12, 24 and 36 months
Number of AADs
Number of AADs at time points following randomization
Measured: 6,12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start3 Nov 2025
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, National Heart Foundation, Australia
- Responsible party
- Principal investigator, Saurabh Kumar, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360939
- Sponsor's protocol ID
- ETH02659
- Acronym
- RadioAblate-VT
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2024
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
- ClinicalTrials.gov ID
- NCT06360939
- Acronym / sponsor ID
- RadioAblate-VT / ETH02659
- Keywords
- catheter ablation, stereotactic body radiation therapy, non invasive, radioablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- University of Sydney, National Heart Foundation, Australia
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 11 Apr 2024 (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.
The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:
- What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months
- What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).
Detailed description
Hypothesis
We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events.
Aims
This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in:
- An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention
- Comparable safety profile (serious adverse events [SAE] and adverse events of special interest [AESI] at 6 months;
- reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Radiation: SBRTSBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging. |
| Catheter ablation | Active comparator | Procedure: CACA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of
- Recurrent monomorphic VT which can include
- PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.
Key exclusion criteria (7 listed)
- Age < 18 years
- Life expectancy < 3 months
- Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
- Unwilling or unable to provide consent
- Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
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 |
|---|---|---|
| SBRTDelivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization | Radiation | Stereotactic body radiation therapy |
| CACA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization. | Procedure or surgery | Catheter ablation |
Primary outcome
VT burden
Time frame: 6 months
Change in proportion of patients with a ≥75% reduction in VT burden at 6 months (number of VT episodes in 6 months post treatment compared to the number of VT episodes in the 6 months prior to randomisation excluding a 6-week blanking period after treatment initiation)
13 secondary outcomes
Recurrent sustained VT
Time frame: 6, 12, 24 and 36 months
VT storm
Time frame: 6, 12, 24 and 36 months
Absolute VT burden
Time frame: 6, 12, 24 and 36 months
Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)
Time frame: At all time points up to 36 months
ICD shocks
Time frame: 6, 12, 24 and 36 months
Hospitalization
Time frame: 6, 12, 24 and 36 months
All cause mortality
Time frame: 6,12, 24 and 36 months
Cardiovascular Mortality
Time frame: 6,12, 24 and 36 months
Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation
Time frame: 6,12, 24 and 36 months
Ventricular function
Time frame: 6,12, 24 and 36 months
Quality of Life as per Short Form - 36 (SF-36) Score
Time frame: 6,12, 24 and 36 months
Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score
Time frame: 6,12, 24 and 36 months
Number of AADs
Time frame: 6,12, 24 and 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT and CA in people with Ventricular Tachycardia and Cardiomyopathies, run by Western Sydney Local Health District at 1 site in Australia.
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 9 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: looking for participants now, as of the sponsor's last update on 18 Feb 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 Australia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saurabh Kumar, MBBS | PhD ((02)88908140 ext. +61, saurabh.kumar@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT burden (time frame: 6 months). 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 18 Feb 2026.