A new minimally invasive treatment for patients with
DO YOU HAVE HEART FAILURE?
If your doctor has told you that you have heart failure you have come to the right place. Medications alone are often not enough for patients suffering from heart failure. Additionally, some patients may not be good candidates for more invasive procedures. If you’re one of these patients, you may qualify for a clinical trial studying a minimally invasive device for heart failure.
This website provides useful information about the ANTHEM HFrEF clinical trial studying Autonomic Regulation Therapy (ART). The information provided here can help you or a loved one determine if they should consider participation in the trial.
CLINICAL TRIAL ELIGIBILITY
1. Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2010 update: a report from the American Heart Association. Circulation. 2010;121(7):e46-e215.
2. Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-1011.
LivaNova USA, Inc.
100 Cyberonics Boulevard
Houston, TX 77058
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE (EUROPE)
Autonomic regulation therapy (ART) is indicated for patients who have moderate to severe heart failure (NYHA Class II/III) with left ventricular dysfunction (EF ≤ 40%), and who remain symptomatic despite stable, optimal heart failure drug therapy.
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS
The VITARIA® System cannot be used on patients with a bilateral vagotomy.
The VITARIA System cannot be used on patients with a history of AV block.
Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with a VITARIA System. Diagnostic ultrasound is not included in this contraindication.
Magnetic Resonance Imaging (MRI) - The VITARIA System is an MR Conditional device that has been
shown to pose no known hazards in a specific MR environment with specified conditions for use. For specific conditions, refer to the VITARIA Physician's Manual. Patients with existing ulcers (gastric, duodenal or other) may have their condition aggravated by ART. Patients with ulcers should be evaluated prior to implantation and monitored following initiation of stimulation. Potential surgery-related adverse events include hematoma, infection, pain and voice alteration (hoarseness). Potential stimulation-related adverse events include dyspepsia (indigestion), dysphagia (difficulty swallowing), dyspnea (difficulty breathing, shortness of breath), increased coughing, laryngismus (throat, larynx spasms), pain, paresthesia (prickling of the skin), pharyngitis (inflammation of the pharynx, throat), satiety (reduced appetite), sensation of stimulation, and voice alteration (hoarseness).