Comparing cardiac radioablation and repeat catheter ablation for high-risk ventricular tachycardia
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
Run by Varian, a Siemens Healthineers Company · NCT05765175 · Data updated 2026-11-12
This study is testing whether a new treatment called cardiac radioablation is better than repeat catheter ablation for people with high-risk ventricular tachycardia who have had their heart rhythm problems come back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 380 (estimated) |
| Sponsor | Varian, a Siemens Healthineers Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Status | Recruiting |
| Started | April 21, 2023 |
| Main results expected | October 2028 |
| Study ends | May 2032 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT05765175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with high-risk refractory VT who have previously undergone catheter ablation and have experienced VT recurrence.
✕Probably not a fit
Patients who do not have recurrent ventricular tachycardia or those who are not candidates for repeat catheter ablation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
RADIATE-VT is a pivotal, multicenter, randomized trial that evaluates the safety and efficacy of cardiac radioablation (CRA) using the Varian CRA System compared to repeat catheter ablation (CA) in patients with high-risk refractory ventricular tachycardia (VT). The study focuses on individuals who have experienced VT recurrence after previous catheter ablation and are candidates for additional procedures. Participants will be monitored for outcomes related to VT management and overall cardiac health.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may improve outcomes for patients with refractory ventricular tachycardia.
How similar studies have gone: Other studies have explored catheter ablation techniques, but the specific approach of cardiac radioablation in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 VT below detection rate of ICD documented by ECG, and
3. Left ventricular ejection fraction (LVEF) ≤49% and
4. Previously underwent at least one standard of care CA for VT.
2. Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
3. Has failed amiodarone therapy or is intolerant to amiodarone:
* Failed amiodarone therapy is defined as: appropriate ICD therapy or sustained monomorphic VT having occurred while the patient was taking amiodarone (minimum cumulative dose of 10 g).
* Intolerant to amiodarone is defined as: previously tried or taken amiodarone but stopped due to medication related side effects or toxicities.
4. Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
5. Presence of an ICD.
6. At least 18 years of age (or meets local age of majority).
7. Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
1. 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).
2. Patients with expected, right ventricular scar only.
3. Any prior radiation to the thorax region of the body.
4. 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.
5. Current use of inotropes.
6. Presence of a left-ventricular assist device (LVAD).
7. Scheduled for LVAD or heart transplant procedures.
8. Presence of a systemic illness likely to limit survival to \< 1 year.
9. VT ablation procedure performed within the prior 2 weeks.
10. Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.
11. \>3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or \>5 induced monomorphic VT morphologies during NIPS testing.
12. Incessant VT that is hemodynamically unstable.
13. Bundle branch reentry (BBR) VT.
14. Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).
15. Patients of childbearing potential who:
* are not on a medically effective means of birth control at the time of screening or do not start a medically effective means of birth control prior to randomization; or
* do not agree to continue medically effective means of birth control until they have completed their assigned therapy; or
* do not agree to be on a medically effective means of birth control if they are treated with CRA after their index CA procedure.
16. Patients enrolled in another clinical study the investigator believes to be in conflict with this clinical investigation.
17. Patients enrolled or planned to be enrolled in another cardiac radioablation clinical study or registry.
18. Patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical investigation.
Where it's running
-
Cedars-Sinai Medical Center
Los Angeles, California, United States Recruiting -
Hartford Hospital
Hartford, Connecticut, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting -
Brigham & Women's Hospital
Boston, Massachusetts, United States Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Recruiting -
University of Missouri
Columbia, Missouri, United States Recruiting
Show 6 more locations
-
Washington University
St Louis, Missouri, United States Recruiting -
The Ohio State University
Columbus, Ohio, United States Recruiting -
University of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States Recruiting -
Medical University of South Carolina
Charleston, South Carolina, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting
Study contacts
- Study coordinator: Claire McCann, PhD
- Email: claire.mccann@varian.com
- Phone: 437.240.4531
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
AI-powered ECG to help diagnose and locate tachycardia in patients with PSVT, WPW, PVC, or VT
A multicenter registry test whether an AI-enabled ECG analysis can help diagnose and localize tachycardia in adults with certain arrhythmias.
-
DuoVT PFA System for Treating Ventricular Tachycardia
This study tests whether the DuoVT Pulsed Field Ablation system can safely and effectively treat Ventricular Tachycardia in people with ischemic heart disease.
-
Sphere VT: Using Sphere-9 Catheter and Affera System to treat recurrent scar-related ventricular tachycardia
This study tests the Sphere-9 catheter and Affera mapping and ablation system in adults with recurring scar-related ventricular tachycardia after a prior heart attack.
-
Parasternal EV-ICD System Pivotal Study
This study tests the Parasternal Extravascular ICD System in adults who need an ICD to see if it can safely provide defibrillation without traditional leads.
-
Real-time intracardiac ultrasound to guide ablation of ventricular arrhythmias
It tests whether using ultrasound inside the heart during PVC or VT ablation can reduce X-ray exposure for adults having these procedures.
-
Arrhythmia mapping with a paddle-shaped multi-electrode catheter
This test uses a new high-density multi-electrode catheter to see if it can safely map atrial and ventricular arrhythmias in adults having catheter mapping and ablation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.