Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)

1. 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).

2. Patients with expected, right ventricular scar only.

3. Any prior radiation to the thorax region of the body.

4. 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.

5. Current use of inotropes.

6. Presence of a left-ventricular assist device (LVAD).

7. Scheduled for LVAD or heart transplant procedures.

8. Presence of a systemic illness likely to limit survival to \< 1 year.

9. VT ablation procedure performed within the prior 2 weeks.

10. Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.

11. \>3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or \>5 induced monomorphic VT morphologies during NIPS testing.

12. Incessant VT that is hemodynamically unstable.

13. Bundle branch reentry (BBR) VT.

14. Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).

15. Patients of childbearing potential who:

* are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or

* do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or

* do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure.

16. Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation.

17. Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry.

18. Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.

What this study is about