RADIATE-VT Clinical Trial

Cardiac RADIoablation versus repeat catheter Ablation: a pivotal randomized clinical Trial Evaluating safety and efficacy for patients with high-risk refractory Ventricular Tachycardia

Cardiac radioablation (CRA) is an experimental treatment that uses targeted beams of radiation to non-invasively treat certain cardiac arrhythmias. The RADIATE-VT clinical trial is a pivotal randomized controlled trial evaluating cardiac radioablation for patients with high-risk refractory ventricular tachycardia (VT) who have experienced VT recurrence after a prior catheter ablation. The purpose of the trial is to compare the safety and efficacy of cardiac radioablation with Varian’s CRA system to repeat standard-of-care catheter ablation.

CAUTION: Varian’s cardiac radioablation system is an investigational device. Limited by United States law to investigational use.

Exclusively for clinical investigation.

TrueBeam

Multi-institutional, multi-national, randomized controlled clinical trial

  • 380
    planned participants
  • 30
    institutions

Study Design

Up to 380 participants with high-risk, refractory ventricular tachycardia (VT) will be enrolled at up to 30 sites. 

Participants will be randomized 1:1 between 2 treatment arms:

  • Repeat standard-of-care catheter ablation
  • Cardiac radioablation with Varian’s CRA system
Eligibility criteria

Patients with refractory VT who meet the following criteria may be eligible:

  • Ischemic and/or nonischemic cardiomyopathy
  • Recurrent sustained monomorphic VT
  • LVEF ≤ 49%
  • Previously underwent a catheter ablation for VT
  • Have failed or are intolerant to amiodarone
  • Have an implantable cardioverter-defibrillator (ICD)
  • Medically and technically a candidate for catheter ablation

Complete inclusion and exclusion criteria can be found on ClinicalTrials.gov

Treatment

Catheter ablation

Study participants randomized to the catheter ablation treatment arm receive standard-of-care catheter ablation.  

Cardiac radioablation

Study participants randomized to the cardiac radioablation treatment arm receive cardiac radioablation with Varian’s CRA system.  Cardiac radioablation involves the use of external beam radiation to precisely deliver a single targeted treatment to the region of the heart identified as the source of the VT. 

The radiation treatment is delivered using a device called a linear accelerator. 

External beam radiation is most commonly used to treat cancer and is also used to treat certain non-cancerous conditions.  Treatment of VT using a linear accelerator (cardiac radioablation) is considered experimental because it is not approved for routine clinical use by the US Food and Drug Administration (FDA) or other regulatory authorities outside the US.

The treatment process typically takes 20-30 minutes from start to finish.  Radiation treatments are often outpatient procedures, and study participants who receive cardiac radioablation are usually able to leave the hospital after the radiation treatment is delivered.

Outcomes measures

The primary objective of the RADIATE-VT clinical trial is to demonstrate that treatment with Varian’s CRA system is safer than and as effective as catheter ablation in participants with high-risk refractory VT. 

The secondary objectives are to compare quality of life and VT burden reduction between the two treatments. 

Learn more about the full study design, inclusion/exclusion criteria, and study endpoints at ClinicalTrials.gov. 

Hospitals enrolling patients in RADIATE-VT

Information on hospitals enrolling patients in RADIATE-VT can be found on the Clinicaltrials.gov website

 

Study Contacts

For more information, contact the Varian Clinical Affairs RADIATE-VT study team.

 

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