Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia
Varian, a Siemens Healthineers Company
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. High-risk refractory VT, defined as: 1. Ischemic and/or nonischemic cardiomyopathy, and 2. Recurrent sustained monomorphic VT, defined as at least one of the following below, documented by ICD interrogation or ECG in the prior 6 months, and having occurred after the last VT ablation: A: ≥3 episodes of monomorphic VT treated with anti-tachycardia pacing (ATP) at least one of which is symptomatic B: ≥1 appropriate ICD shock C: ≥3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP D: sustained monomorphic V…
Interventions
- DeviceVarian 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.
- ProcedureCatheter Ablation (CA)
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Locations (11)
- Cedars-Sinai Medical CenterLos Angeles, California
- Hartford HospitalHartford, Connecticut
- Brigham & Women's HospitalBoston, Massachusetts
- Mayo ClinicRochester, Minnesota
- University of MissouriColumbia, Missouri
- Washington UniversitySt Louis, Missouri