LivaNova USA, Inc.

100 Cyberonics Boulevard

Houston, TX 77058

763.220.4110

IMPORTANT SAFETY INFORMATION

(US) CAUTION–Investigational device. Limited by Federal (or United States) law to investigational use.

(CANADA) CAUTION–Investigational Device. To be Used by Qualified Investigators Only.

 

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) - If MRI is required in a patient with the VITARIA System, consult 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).

AM I ELIGIBLE?

HAVE YOU BEEN DIAGNOSED WITH HEART FAILURE?

If yes, you may consider participating in the FDA and Health Canada approved clinical study called ANTHEM-HFrEF, which is evaluating the safety and efficacy of Autonomic Regulation Therapy.

 

A clinical trial is a research study to answer specific health related questions. The ANTHEM-HFrEF clinical trial will determine whether Autonomic Regulation Therapy (ART) plus medical therapy is safe and more effective than medical therapy alone for the treatment of heart failure. The trial is seeking up to 1,000 adult men and women with heart failure at selected medical centers in the United States, Canada, and Europe. The investigators are doctors who specialize in treating heart failure.

AM I ELIGIBLE?

Are you 18 years or older with:

Stable symptomatic heart failure NYHA class III; or NYHA class II with a heart failure hospitalization in the previous 6 months

Left ventricular ejection fraction (EF) ≤ 35%, as confirmed by core

echocardiography laboratory during screening

Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and having a baseline distance of between 150 and 450 meters

If you answered ‘YES’ to these questions you may be eligible to participate depending upon other inclusion and exclusion criteria.

SPEAK TO YOUR DOCTOR TO LEARN MORE

WHY SHOULD I VOLUNTEER?

By participating in a clinical study you can:

  • Take an active role in your own health care

  • Obtain expert medical care at leading healthcare facilities during the clinical trial 

  • Help others by contributing to medical research

†Before you join a clinical study you should know as much as possible about the study. It is important for you to feel very comfortable asking questions and receiving complete answers prior to deciding to participate or not in the study. You should feel comfortable not participating in the study if you so choose.

WHAT IS EXPECTED OF ME IF I PARTICIPATE?

1. SIGN THE CONSENT FORM after understanding details about the study including risks, benefits and your responsibility as a participant


2. COMPLETE ENROLLMENT AND EVALUATION STEPS, which will likely include:

  • Medical history and physical examination

  • Tests to check your overall health status (echocardiogram, blood and Holter Monitor 

  • Questionnaires

3. PARTICIPATE IN FOLLOW-UP VISITS

Return for clinical visits throughout the study. You will be reimbursed for travel associated with follow-up visits, which will include:

  • ART stimulation adjustments until therapy target established

  • Subsequent follow-up visits consisting of scheduled visits every 3 months after therapy adjustment during the first 12 months, and scheduled visits every 4 months thereafter
     

HOW LIKELY AM I TO RECEIVE INVESTIGATIONAL THERAPY?

YOU ARE MORE LIKELY TO RECEIVE ART THAN NOT RECEIVE ART IN THE CLINICAL TRIAL

 

Everyone in the clinical trial will continue receiving the best medical (drug) therapy available for heart failure from their doctor. In addition, 2 out of every 3 eligible patients will receive ART.

3 Eligible Patients

2 receive ART and drug therapy

1 receives drug therapy alone

Click here to watch a short video and learn more