An interventional study of SBRT and CA in Ventricular Tachycardia, Cardiomyopathies and Arrhythmias, Cardiac, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Treatment
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:
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:
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's planned enrollment of 60 is below the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging.
Radiation: SBRT
CA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease)
Procedure: CA
Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization
CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.
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)
Time frame: 6 months
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
Time frame: 6, 12, 24 and 36 months
VT storm
VT storm (three or more documented episodes of VT within 24 hours or incessant VT)
Time frame: 6, 12, 24 and 36 months
Absolute VT burden
Absolute percentage reduction in VT burden compared to pre-ablation
Time frame: 6, 12, 24 and 36 months
Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)
1. SAE and AESI related to effects of SBRT 2. SAE and AESI related to standard care e.g. medical anti-arrhythmic drug therapy or catheter ablation or heart transplantation
Time frame: At all time points up to 36 months
ICD shocks
Implantable Cardioverter Defibrillator shocks
Time frame: 6, 12, 24 and 36 months
Hospitalization
Cardiovascular as well as specifically heart failure and arrhythmia
Time frame: 6, 12, 24 and 36 months
All cause mortality
All cause mortality
Time frame: 6,12, 24 and 36 months
Cardiovascular Mortality
Cardiovascular mortality
Time frame: 6,12, 24 and 36 months
Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation
Composite outcome as above
Time frame: 6,12, 24 and 36 months
Ventricular function
As determined by echocardiography (ejection fraction, speckle tracking echocardiography)
Time frame: 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) \[0-100 scale, 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability\].
Time frame: 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. \[0-100 scale, 100 equivalent to maximum concern\]
Time frame: 6,12, 24 and 36 months
Number of AADs
Number of AADs at time points following randomization
Time frame: 6,12, 24 and 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Jun 2026, 7 months after the start.
Of 85 non-industry interventional studies with no phase under Tachycardia, Ventricular, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 70. This study's planned 7 months is below that.
Counting every sponsor, half of 125 studies reached it within 36 months; a quarter within 20 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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Western Sydney Local Health District