RADIO-STAR Trial

The study is designed so the serious adverse event rate does not exceed 34%, based on complication rates from surgical cardiac sympathetic denervation; 13 participants are required. The trial is not powered to assess clinical efficacy; effects on arrhythmia burden are outside its main scope. The absence of a control group means observed changes in ICD therapy burden may be confounded by concurrent care. RADIO-STAR is a first-in-human phase 1 clinical trial evaluating safety, feasibility, and dose selection for image-guided radiotherapy to the stellate ganglia in patients with recurrent ventricular arrhythmias. The primary objective is to determine whether image-guided stellate ganglion radiotherapy is feasible and safe.