The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said.
Patients enrolled in the trial are slated to be randomized on a two-to-one ratio to be implanted with Vitaria or standard medical treatment. The primary endpoints are the event-free rate at 90 days from all device- and implantation-related serious adverse events and the composite rate of cardiovascular mortality and heart failure hospitalization for the duration of the study, according to ClinicalTrials.gov. The trial is due for primary completion in December 2021 and full completion the following December.
“LivaNova is dedicated to changing lives through the development and introduction of novel technologies, which address large unmet needs in the global medical community. Autonomic regulation therapy is based on our market-leading experience derived from VNS therapy, which is used to treat other disorders,” neuromodulation general manager Edward Andrle said in prepared remarks. “The Anthem-HFrEF Pivotal Study brings us closer to offering the Vitaria system to a large segment of the more than 20 million people currently battling heart failure around the world.”
“Patients with advanced heart failure continue to need additional and complementary therapy options, since drug treatment alone has slowed but not stopped heart failure progression,” added lead investigator Dr. Ron Oren of the Heart and Vascular Institute in Cedar Rapids. “We are pleased to participate in this important study to critically evaluate the safety and efficacy of autonomic regulation therapy delivered by the Vitaria system.”