AM I ELIGIBLE?
HAVE YOU BEEN DIAGNOSED WITH HEART FAILURE?
If yes, you may consider participating in a European post-approval 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 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
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 ART?
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
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).