RADIATE-VT is a pivotal, multicenter, randomized trial comparing safety and efficacy between cardiac radioablation (CRA) using the Varian CRA System and repeat catheter ablation (CA), for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after CA and are candidates for additional CA.
Ischemic and/or nonischemic cardiomyopathy, and
Left ventricular ejection fraction (LVEF) ≤49% and
Previously underwent at least one standard of care CA for VT.
Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
Contraindication to a CA procedure for VT (e.g., presence of mobile LV thrombus, active systemic infection, active ischemic or other reversible causes of VT).
Patients with expected, right ventricular scar only.
Any prior radiation to the thorax region of the body.
Known medical conditions associated with higher risk of radiotherapy complications in the judgement of the radiation oncologist (i.e., active connective tissue disorders, interstitial lung disease, etc.) that would preclude safe delivery of CRA.
Parallel
Varian Cardiac Radioablation (CRA)
DeviceSubjects randomized to CRA will be treated with the Varian CRA system according to a uniform CRA protocol. A dose of 25 Gy in a single fraction is prescribed to the planning target volume (PTV), and delivered using a stereotactic body radiotherapy (SBRT) technique.
Catheter Ablation (CA)
Procedure/SurgerySubjects randomized to the CA arm will be treated according to a uniform CA protocol.
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.
Change in quality of life at 6 weeks post treatment:
Change in quality of life at 6 weeks post treatment measured by the Short Form Health Survey 36 (SF-36) Health Change Question. This item asks the subject to rate their health in general compared to one year ago in a 5-point scale of 1 (much better), 2 (somewhat better), 3 (about the same), 4 (somewhat worse), 5 (much worse).
VT burden reduction
VT burden reduction measured as a ≥75% reduction in appropriate ICD therapies (ATP, shock), comparing a 6-month period before randomization and a 6-month period starting after a 30-day period immediately post-randomization.
Change in quality of life (Social Functioning) at 6 weeks post treatment
Change in quality of life (Social Functioning) measured by the Short Form Health Survey 36 (SF-36) Social Functioning item (social activities in past 4 weeks). This item asks the subject to rate how much of the time their physical health or emotional problems interfered with their social activities in the past 4 weeks in a 5-point scale of 1 (All of the time), 2 (Most of the time), 3 (Some of the time), 4 (A little bit of the time), 5 (None of the time).
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