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)
PALO ALTO, Calif., May 19, 2023 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that the first participant has been treated in the RADIATE-VT™ clinical trial (NCT 05765175) at Washington University School of Medicine in St. Louis, MO. RADIATE-VT is the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation (CRA) compared to catheter ablation for patients with high-risk, refractory ventricular tachycardia (VT). The cardiac radioablation treatments will be planned and delivered with Varian’s CRA system.
“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,” said Deepak “Dee” Khuntia, M.D., Senior Vice President and Chief Medical Officer of Varian. “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 is a fast, abnormal heart rate that affects patients’ quality of life and may lead to sudden cardiac arrest. Current treatments for ventricular tachycardia include antiarrhythmic medications, implantable cardioverter-defibrillators, or invasive catheter ablation procedures, but these treatments are often insufficient in controlling VT and can be associated with significant side effects.1234 The RADIATE-VT trial will evaluate cardiac radioablation as a new therapeutic alternative. CRA involves precise targeting and accurate delivery of focused radiation beams to the area of the heart where the arrhythmia originates.
The cardiac radioablation treatment planning and delivery process requires close collaboration among electrophysiologists, who specialize in treating cardiac arrhythmias, and radiation oncologists, who specialize in treating cancer and other conditions with radiation therapy. Varian’s CRA system, which received FDA Breakthrough Device designation, is a non-invasive, end-to-end solution designed to facilitate the clinical partnership between these physicians.
“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,” said Daniel Cooper, M.D., electrophysiologist and RADIATE-VT Principal Investigator at Washington University. “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.”
CAUTION: Varian’s cardiac radioablation system is an investigational device and is limited by United States law to investigational use.
Not available for sale in any market and no guarantee of future commercialization or feature availability.
About Varian
At Varian, a Siemens Healthineers company, we envision a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help care providers around the globe treat millions of patients each year. Today, as a Siemens Healthineers company, we support every step of the cancer care journey – from screening to survivorship. From advanced imaging and radiation therapy, to comprehensive software and services, to interventional radiology, we are harnessing the power of our perspective while also pursuing clinical research to create a more efficient, and more personalized care pathway. Because, for cancer patients everywhere, their fight is our fight. For more information, visit http://www.varian.com.
Press Contact
Katie Villany
Varian Corporate Communications
Katie.villany@varian.com
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2 Sapp JL, Wells GA, Parkash R, Stevenson WG, Blier L, Sarrazin JF, et al. Ventricular Tachycardia Ablation versus Escalation of Antiarrhythmic Drugs. N Engl J Med [Internet]. 2016/05/06. 2016;375(2):111–21.
3 Tokuda M, Kojodjojo P, Tung S, Tedrow UB, Nof E, Inada K, et al. Acute failure of catheter ablation for ventricular tachycardia due to structural heart disease: causes and significance. J Am Hear Assoc [Internet]. 2013/06/04. 2013;2(3):e000072.
4 Stevenson WG, Wilber DJ, Natale A, Jackman WM, Marchlinski FE, Talbert T, et al. Irrigated Radiofrequency Catheter Ablation Guided by Electroanatomic Mapping for Recurrent Ventricular Tachycardia After Myocardial Infarction The Multicenter Thermocool Ventricular Tachycardia Ablation Trial. Circulation [Internet]. 2008/12/10. 2008;118(25):2773–82.
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