This study compares two arms - the current standard of care catheter ablation for Ventricular Tachycardia compared to stereotactic radiotherapy to non-invasively ablate ventricular tachycardia using a novel non-invasive ECG based body surface mapping technology. This allows investigators to identify ventricular tachycardia circuits to target for subsequent radio ablation. To summarize, the current standard of care invasive catheter ablation to the non-invasive radio ablation.
Patient aged ≥55 years of age
Cardiomyopathy (Left ventricular ejection fraction ≤ 35% and ICD in situ) AND
Recurrent VT events despite previous CA OR
VT events requiring intervention and PAINESD score ≥ 15
Patients with NYHA Class IV heart failure &/ or with LVAD in situ
Patients not expected to live for more than one year for any reason
Patients who have previously received thoracic radiotherapy
Patients who are enrolled in another randomized clinical trial
Parallel
Control - Catheter Ablation for VT
Procedure/SurgeryCurrently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, "scar", identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours .
Treatment - Non-Invasive Radio Ablation for VT
Procedure/SurgeryPatients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.
Time to composite event
Composite event including death at any time, appropriate ICD shock after 14 days, ventricular tachycardia storm after 14 days, treated sustained ventricular tachycardia below the detection rate of the ICD after 14 days
Appropriate ICD ATP at any time or after 14 days
Any appropriate therapy delivered from the ICD at least 14 days post randomization
Appropriate shocks
Appropriate ICD shocks at any time post randomization
VT storm at any time or after 14 days
3 or more episodes of VT occurring within 24 hours at any time post randomization
Sustained VT not treated by ICD at any time or after 14 days
Time to sustained VT treated with appropriate any type of manual cardioversion after 14 days Any sustained VT greater than 30 seconds requiring manual cardioversion (ICD, external or pharmacologic)
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