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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)

NCT05765175 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Varian, a Siemens Healthineers Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2026-05-31
Completion
2030-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765175 on ClinicalTrials.gov