Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Sydney | OTHER |
| National Heart Foundation, Australia | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy | Experimental | SBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging. |
|
| Catheter ablation | Active Comparator | CA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6, 12, 24 and 36 months |
| VT storm |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saurabh Kumar, MBBS | PhD | Contact | (02)88908140 | +61 | saurabh.kumar@health.nsw.gov.au |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Recruiting | Westmead | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D009202 | Cardiomyopathies |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CA | Procedure | CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization. |
|
VT storm (three or more documented episodes of VT within 24 hours or incessant VT) |
| 6, 12, 24 and 36 months |
| Absolute VT burden | Absolute percentage reduction in VT burden compared to pre-ablation | 6, 12, 24 and 36 months |
| Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) |
| At all time points up to 36 months |
| ICD shocks | Implantable Cardioverter Defibrillator shocks | 6, 12, 24 and 36 months |
| Hospitalization | Cardiovascular as well as specifically heart failure and arrhythmia | 6, 12, 24 and 36 months |
| All cause mortality | All cause mortality | 6,12, 24 and 36 months |
| Cardiovascular Mortality | Cardiovascular mortality | 6,12, 24 and 36 months |
| Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation | Composite outcome as above | 6,12, 24 and 36 months |
| Ventricular function | As determined by echocardiography (ejection fraction, speckle tracking echocardiography) | 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]. | 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] | 6,12, 24 and 36 months |
| Number of AADs | Number of AADs at time points following randomization | 6,12, 24 and 36 months |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |