Heart failure (HF) is a major public health burden that is currently estimated to affect greater than 5 million patients in the United States and over 6.5 million patients in Europe. In the U.S. alone, each year, more than 600,000 new cases of HF are diagnosed, and over 1 million hospitalizations occur due to this disease. Annual cost to the US healthcare system has been estimated at $38 billion.
NYHA Class III Heart Failure is associated with poor life expectancy, as the annual mortality rate is approximately 15-20% with five-year mortality approaching 50% despite standard-of-care therapy. Death in these patients is an ever-present threat as they may experience acute decompensated heart failure or sudden cardiac death at any time.
The purpose of this clinical trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).
The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.