The trial marks the first international, multi-center, randomized controlled study aimed at assessing the safety and effectiveness of cardiac radioablation (CRA) in comparison to catheter ablation for patients with high-risk, refractory ventricular tachycardia (VT)
Varian, a Siemens Healthineers company, made an announcement regarding the commencement of the RADIATE-VT clinical trial (NCT 05765175) at Washington University School of Medicine in St. Louis, Missouri.
The trial marks the first international, multi-centre, randomised controlled study aimed at assessing the safety and effectiveness of cardiac radioablation (CRA) in comparison to catheter ablation for patients with high-risk, refractory ventricular tachycardia (VT). Varian’s CRA system will be utilised for the planning and administration of cardiac radioablation treatments.
Varian senior vice president and chief medical officer Deepak Dee Khuntia said: “We’re pleased that the first participant has been treated in this landmark clinical trial. Varian is committed to pursuing clinical research that has the potential to enhance the care experience and improve outcomes for patients.
“We view the RADIATE-VT trial as an important opportunity to better understand how our innovative technology and solutions can be used in clinical settings that extend beyond cancer care.”
Ventricular tachycardia refers to a rapid, abnormal heart rate that negatively impacts patients’ quality of life and can potentially result in sudden cardiac arrest. The existing treatments for ventricular tachycardia include antiarrhythmic medications, implantable cardioverter-defibrillators, or invasive catheter ablation procedures. However, these treatments often fall short in effectively managing VT and may be associated with notable side effects. The RADIATE-VT trial aims to evaluate cardiac radioablation as a novel therapeutic alternative. CRA involves the precise targeting and accurate delivery of focused radiation beams to the specific area of the heart where the arrhythmia originates.
The process of planning and delivering cardiac radioablation treatment necessitates close collaboration between electrophysiologists, who specialise in treating cardiac arrhythmias, and radiation oncologists, who specialise in using radiation therapy to treat cancer and other conditions. Varian’s CRA system, which has been granted FDA Breakthrough Device designation, serves as a non-invasive, end-to-end solution designed to facilitate the clinical partnership between these physicians.
RADIATE-VT principal investigator Daniel Cooper said: “This trial is a significant step toward gathering the necessary clinical evidence to evaluate whether cardiac radioablation with Varian’s CRA system as a non-invasive treatment option is safe and effective compared to catheter ablation for these patients.
“Patients who experience ventricular tachycardia recurrence after conventional medical and ablative therapy have limited treatment options with results that are often disappointing, making it vital to investigate treatments that have the potential to improve future outcomes.”