Global medical technology and innovation company, LivaNova PLC, conducts the large medical device study ANTHEM-HFrEF to evaluate whether autonomic regulation therapy will benefit patients with symptomatic heart failure and reduced ejection fraction. The trial is performed by the US-based CRO CCSF, with SCIRENT responsible for managing the European sites.
The prospective, international, randomized, controlled clinical trial, ANTHEM-HFrEF, is a pivotal study of LivaNova’s VITARIA® System, which delivers a completely new approach for treating patients with heart failure which is called Autonomic Regulation Therapy (ART). VITARIA® delivers ART using Vagus Nerve Stimulation (VNS) and is intended for patients who experience symptoms of heart failure despite receiving guideline-directed medical therapy. Recent results of the ANTHEM-HF trial were presented at the American College of Cardiology and World Congress of Cardiology Virtual Meeting in March 2020.
“This trial has the potential to demonstrate that ART adds significant symptomatic and clinical outcome benefit to current treatments, thereby improving the health and quality of life of patients with heart failure,” said Marvin Konstam MD, Chief Physician Executive of The CardioVascular Center at Tufts Medical Center, Boston, and Chairman of the ANTHEM-HFrEF Pivotal Study Steering Committee.
The VITARIA System received CE Mark approval in 2015 and has been granted Expedited Access Pathway as a breakthrough technology by the U.S. Food and Drug Administration (FDA). If approved by FDA, it could be the first in its class for treating chronic heart failure.
“As we learn more from our ART research, we continue to be excited about its potential as a breakthrough treatment to meaningfully improve the lives of patients with advanced chronic heart failure,” said Bryan Olin, PhD and Senior Vice President of Clinical, Quality and Regulatory Affairs at LivaNova.
To learn more about the LivaNova VITARIA System and the treatment of heart failure with ART, visit www.ARTforHeartFailure.com.
Selected manuscripts and abstracts on ART:
Vagus Nerve Stimulation Provides Multiyear Improvements in Autonomic Function and Cardiac Electrical Stability in the ANTHEM-HF Study
Bruce D. Nearing, PhD, Inderjit S. Anand, MD, Imad Libbus, PhD, Lorenzo A. DiCarlo, MD, Bruce H. KenKnight, PhD and Richard L. Verrier, PhD
Impact of Autonomic Regulation Therapy in Patients with Heart Failure: The ANTHEM-HFrEF Pivotal Study Design
Konstam MA, Udelson JE, Butler J, Lein HU, Parker JD, Teerlink JR, Wedge PM, Saville BR, Ardell JL, Libbus I, DiCarlo LA
Autonomic regulation therapy to enhance myocardial function in heart failure patients: the ANTHEM-HFpEF study
DiCarlo LA, Libbus I, Kumar HU, Mittal S, Premchand RK, Amurthur B, KenKnight BH, Ardell JL, Anand IS