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)
RADIATE-VT
1 other identifier
interventional
380
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 13, 2023
CompletedStudy Start
First participant enrolled
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
ExpectedApril 22, 2026
April 1, 2026
3 years
February 15, 2023
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.
Treatment through 12 months post-treatment
Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.
Freedom from death, and appropriate ICD shock, and VT storm, where death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization.
Death will be counted from randomization through 12 months, and shock and storm will be counted starting after a 30-day period immediately post-randomization and continuing through 12 months post randomization
Secondary Outcomes (3)
Change in quality of life at 6 weeks post treatment:
From baseline through 6 weeks post treatment
VT burden reduction
From 6 months before randomization through to a 6 month period starting after a 30-day period immediately post-randomization
Change in quality of life (Social Functioning) at 6 weeks post treatment
From baseline through 6 weeks post treatment
Study Arms (2)
Repeat catheter ablation (CA)
ACTIVE COMPARATORVarian Cardiac Radioablation (CRA)
EXPERIMENTALInterventions
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.
Subjects randomized to the CA arm will be treated according to a uniform CA protocol.
Eligibility Criteria
You may qualify if:
- High-risk refractory VT, defined as:
- Ischemic and/or nonischemic cardiomyopathy, and
- 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
- Left ventricular ejection fraction (LVEF) ≤49% and
- Previously underwent at least one standard of care CA for VT.
- Presence of a clinical indication for a repeat CA procedure for scar-mediated VT in the judgement of the treating investigator.
- 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.
- Deemed to be medically and technically a candidate for further CA by the electrophysiologist investigator.
- Presence of an ICD.
- +2 more criteria
You may not qualify if:
- 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).
- Patients with expected, right ventricular scar only.
- Any prior radiation to the thorax region of the body.
- 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.
- Current use of inotropes.
- Presence of a left-ventricular assist device (LVAD).
- Scheduled for LVAD or heart transplant procedures.
- Presence of a systemic illness likely to limit survival to \< 1 year.
- VT ablation procedure performed within the prior 2 weeks.
- Polymorphic VT or ventricular fibrillation (VF) as the primary clinical heart rhythm, as indicated by 12-lead ECG and/or ICD interrogation.
- \>3 distinct clinical monomorphic VT morphologies on ICD interrogation since the prior CA, or \>5 induced monomorphic VT morphologies during NIPS testing.
- Incessant VT that is hemodynamically unstable.
- Bundle branch reentry (BBR) VT.
- Pregnant and/or breastfeeding. (Patient denial is sufficient for enrollment).
- Patients of childbearing potential who:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Missouri
Columbia, Missouri, 65211, United States
Washington University
St Louis, Missouri, 63110, United States
The Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
March 13, 2023
Study Start
April 21, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
May 1, 2030
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share