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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVarian, a Siemens Healthineers Company

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Varian Cardiac Radioablation (CRA)
  • Catheter Ablation (CA)

Treatment groups

380 Participants
are divided into 2 treatment groups