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RADIATE-VT: Cardiac Radioablation vs. Catheter Ablation for Ventricular Tachycardia

The RADIATE-VT study is comparing two treatments for high-risk, recurring ventricular tachycardia (VT), a fast and irregular heartbeat, in patients who have already had a catheter ablation. This study is testing the safety and effectiveness of Varian Cardiac Radioablation (CRA) against repeat Catheter Ablation (CA). You might be eligible if you are 18 or older, have ischemic (heart disease-related) or nonischemic cardiomyopathy, and have experienced recurring VT after a previous CA. The study will look at how well each treatment prevents death, appropriate ICD (implantable cardioverter-defibrillator) shocks, and VT storms (multiple VT episodes) for 12 months, and also track serious side effects for 12 months. The current recruitment status is unclear, and the study plans to enroll 380 participants.

Study design
This is a randomized interventional study, meaning participants will be randomly assigned to receive either Varian Cardiac Radioablation or Catheter Ablation. The study plans to enroll 380 participants.
What's involved
You would receive either Varian Cardiac Radioablation (a single treatment of 25 Gy) or a Catheter Ablation procedure. The study will track your health for 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after treatment to assess outcomes like death, ICD shocks, and VT storms, and for 12 months to track serious side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05765175

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)

Recruiting
NAAges 18+InterventionalTreatment
Varian, a Siemens Healthineers Company
~380 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:Varian Cardiac Radioablation (CRA)Catheter Ablation (CA)

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)
Measured over Treatment through 12 months post-treatment
+1 more outcome measured

Conditions

Tachycardia, Ventricular

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Ventricular Tachycardia

NCT05765175

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham & Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • Hartford Hospital

    Hartford, Connecticutstudy coordinator listed

    Recruiting

  • Mayo Clinic

    Rochester, Minnesotastudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

  • The Ohio State University

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • University of Missouri

    Columbia, Missouristudy coordinator listed

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Claire McCann, PhD
[email protected]
437.240.4531
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Co-primary safety endpoint: freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs)Treatment through 12 months post-treatment

    Freedom from treatment-attributed (i.e., probably or definitely related) serious adverse events (SAEs), evaluated from treatment through 12 months post-treatment.

  • Co-primary efficacy endpoint: Freedom from death, and appropriate ICD shock, and VT storm.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

    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.