None listed
Conditions
Brief summary
Ventricular tachycardia (VT) is a heart rhythm abnormality which typically affects people with underlying heart disease (cardiomyopathy). There are a number of patients who do not have any alternative treatment options. Stereotactic ablative radiotherapy involves the delivery of high-dose radiation non-invasively with high precision and will be used to treat the part of the heart that is causing VT. In this study, we will investigate whether the use of cardiac stereotactic ablative body radiotherapy (SABR) reduces the number of ventricular tachycardia events in the patient. The effectiveness the radiation treatment will be done by assessing the toxicity and quality of life both before and after the radiation delivery.
Interventions
All participants with VT will screened to meet the eligibility criteria by the treating cardiologist.
They will then undergo ECG and cardiac CT scans to determine the region of the heart that is causing the VT events. These will take approximately 1 hour each.
Each participant will attend radiation oncology for the radiotherapy simulation session typically within a week of the cardiac screening session. During the radiotherapy simulation session, they will have two CT scans of the chest region
All participants with VT will screened to meet the eligibility criteria by the treating cardiologist. They will then undergo ECG and cardiac CT scans to determine the region of the heart that is causing the VT events. These will take approximately 1 hour each. Each participant will attend radiation oncology for the radiotherapy simulation session typically within a week of the cardiac screening session. During the radiotherapy simulation session, they will have two CT scans of the chest region: one being conventional CT scan and the second will be a gated 4D CT scan. This session takes about 1 hour. The imaging data from cardiology and radiation oncology will be combined in the radiotherapy treatment planning system to help determine the region of the heart that will be treated with a dose of 25 Gy in 1 treatment fraction. This will be done under the direction of the radiation oncologist and cardiologist. The treatment plan will be reviewed by the trial team and then undergo the radiotherapy quality assurance processes prior to treatment. This is followed by the radiation treatment session in radiation oncology on the linear accelerator. The treatment session will occur between 1 to 2 weeks after the radiotherapy simulation session. The radiation beam will be delivered in several arcs targeting the region of interest. Cone-beam CT imaging will be performed at the start and during the treatment to ensure we are irradiating the region of interest in the heart. The time required for the radiotherapy session will be approximately one hour. The radiotherapy treatment will be delivered by the radiation therapists with the radiation oncologist and cardiologist attending for the duration of the treatment.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The participant must have documented sustained monomorphic ventricular tachycardia as documented on either a 12-lead ECG or intracardiac ICD interrogation — OR— b. Monomorphic PVCs documented on a 12-lead ECG. 2. The patient must have failed or become intolerant to at least one antiarrhythmic medication (amiodarone, sotalol, or mexiletine). –AND— 3. The participant must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure (e.g., LV thrombus, severe pulmonary disease), or have VT thought to arise from a protected location (e.g., epicardial VT with history of previous cardiac surgery). 4. Participant must have either at least 3 VT episodes (sustained VT, ICD ATP or ICD shock) over previous 6 months prior to enrolment –OR— b. >20% PVC burden with a cardiomyopathy (LVEF<50%) 5. Participant must be deemed medically fit for stereotactic ablative body radiotherapy by the treating cardiologist and radiation oncologist. 6. Participant must be over the age of 18 years old. 7. Participant must have willingness to provide informed consent and a willingness to participate and comply with the study requirements.
Exclusion criteria
1. Prior radiotherapy within the treatment field 2. Heart failure dependent on inotropes or left-ventricular assist device 3. Ventricular fibrillation, >3 distinct clinical VT morphologies or > 5 VT induced VT morphologies during previous electrophysiology studies. 4. Advanced myocardial scar substrate that would require stereotactic delivery to a target volume deemed unsafe by the treating physician 5. Patient must not be pregnant and/or breastfeeding and must have a negative pregnancy test within 14 days of study entry.
Outcome results
None listed