St. Luke’s in Cedar Rapids became the first site in an international clinical trial to test a new device that may potentially offer therapy for chronic heart failure. This Cedar Rapid hospital represents one of 100 clinical investigational sites—50 in America and 50 in other countries—to engage in the ANTHEM-HFrEF, a clinical trial organized to determine the benefits for the heart failure patients of a new device development by England-based medical manufacturer called LivaNova. St. Lukes has been testing the device called the Vitaria System—one that is surgically implanted into patients.
The ANTHEM-HFrEF Study
The study is a multi-center randomized controlled clinical trial to evaluate Autonomic Regulation Therapy with the VITARA system in patients with symptomatic heart failure and reduced ejection fraction. CCTrials are involved as a CRO, and the study runs till 2022. The study sponsor targets 800 subjects for the study.
Amy Schweer reports that since the study has commenced, two patients have had the surgical implant and “everything has been positive.”
What is the Vitaria System?
The Vitaria System, designed to deliver autonomic regulation therapy (ART) through vagus nerve stimulation (VNS), was developed for patients who experienced symptoms of heart failure—even after guideline-directed medical therapy. According to another written report, it secured the European CE-Mark in 2015 while the US FDA granted expedited access pathway designation last year.
About UnityPoint Health-St. Lukes
This provider is one of America’s most integrated systems. Their physician-led team of professionals communicates clearly and effectively to address a patient’s health care in the most appropriate setting: whether that is a clinic, a hospital, or at home. Through relationships with more than 280 physician clinics, 37 hospitals in metropolitan and rural communities and home care services throughout its nine regions, UnityPoint Health provides care throughout Iowa, western Illinois, and southern Wisconsin. UnityPoint Health entities employ more than 30,000 employees, working toward innovative advancements to deliver the Best Outcome for Every Patient Every Time.
Each year, through more than 4.5 million patient visits, UnityPoint Health, UnityPoint Clinic, and UnityPoint at Home provide a full range of coordinated care to patients and families. With projected annual revenues of $3.7 billion, UnityPoint Health is the nation’s 13th largest nonprofit health system and the fourth largest nondenominational health system in America.
Dr. Jared Kray, Clinic of Iowa, vascular surgeon