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?

Potential Candidate Scenario

Unique Identifier:

1. Does the patient have NYHA class II or III heart failure?


2. Does the patient have an EF≤35%


3. Has the patient been stable on GDMT for a minimum of 4 weeks?


4. The patient does NOT have a planned Ventricular Assist Device (VAD)
implant, organ transplant, or ablation procedure in the next 6-months?

You must have all YES answers to qualify as a potential candidate for ANTHEM HFrEF

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