Varian, a Siemens Healthineers company, has secured an investigational device exemption by the U.S. Food and Drug Administration (FDA) for the Radiate-VT clinical trial.
The trial will evaluate the safety and efficacy of cardiac radioablation compared with repeat catheter ablation for patients with high-risk refractory ventricular tachycardia. The company said the study will be international, multicenter, and randomized controlled.
Varian also said that initial approval for the trial has been granted for 80 patients at 10 U.S. sites. Total enrollment is planned for 380 patients in up to 30 centers around the world.
