NCT05765175

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)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (estimated)
• Sponsor: Varian, a Siemens Healthineers Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Tachycardia, Ventricular

Interventions

Type	Name	Description
DEVICE	Varian Cardiac Radioablation (CRA)	Subjects 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.
PROCEDURE	Catheter Ablation (CA)	Subjects randomized to the CA arm will be treated according to a uniform CA protocol.

Timeline

• Start date: 2023-04-21
• Primary completion: 2026-05-01
• Completion: 2030-05-01
• First posted: 2023-03-13
• Last updated: 2025-05-20

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study