Actively Recruiting
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)
Led by Varian, a Siemens Healthineers Company · Updated on 2026-04-22
380
Participants Needed
11
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High-risk refractory ventricular tachycardia with ischemic and/or nonischemic cardiomyopathy
- Recurrent sustained monomorphic ventricular tachycardia documented by ICD or ECG in the prior 6 months after last VT ablation
- At least 3 episodes of monomorphic VT treated with anti-tachycardia pacing, with at least one symptomatic, or
- At least 1 appropriate ICD shock, or
- At least 3 episodes of sustained monomorphic VT within 24 hours treated with ICD shock or ATP, or
- Sustained monomorphic VT below ICD detection rate documented by ECG
- Left ventricular ejection fraction of 49% or less
- Previously had at least one standard of care catheter ablation for VT
- Clinical indication for repeat catheter ablation for scar-mediated VT as judged by investigator
- Failed or intolerant to amiodarone therapy
- Medically and technically eligible for further catheter ablation as judged by electrophysiologist
- Presence of an implantable cardioverter defibrillator
- At least 18 years old or meets local age of majority
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Contraindications to catheter ablation for VT (e.g., mobile left ventricular thrombus, active systemic infection, active ischemic or reversible VT causes)
- Expected right ventricular scar only
- Previous radiation to the chest area
- Medical conditions increasing radiotherapy risk (e.g., active connective tissue disorders, interstitial lung disease)
- Current use of inotropes
- Presence of a left-ventricular assist device
- Scheduled for left-ventricular assist device or heart transplant
- Systemic illness likely to limit survival to less than 1 year
- VT ablation within prior 2 weeks
- Polymorphic VT or ventricular fibrillation as primary heart rhythm
- More than 3 distinct monomorphic VT morphologies since prior catheter ablation or more than 5 induced during testing
- Incessant, hemodynamically unstable VT
- Bundle branch reentry ventricular tachycardia
- Pregnant or breastfeeding
- Women of childbearing potential not using or unwilling to use effective birth control
- Participation in conflicting clinical studies or cardiac radioablation studies
- Any other medical or laboratory condition precluding participation as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
University of Missouri
Columbia, Missouri, United States, 65211
Actively Recruiting
6
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
7
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15260
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
C
Claire McCann, PhD
CONTACT
D
David J Harrington
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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