Location: Las Vegas
Compensation: Patient receives: - Device arm compensation: $780 / - Treatment arm compensation: $650
Smokers Allowed: Yes
The purpose of this clinical study is to determine whether Baroreflex Activation Therapy™ with the Barostim neo system is safe and reduces the risk of cardiovascular mortality and heart failure events 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.
For all subjects, study visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-activation (post anticipated activation for medical management). Long-term follow-up visits will occur quarterly between 12 and 24 months, and semi-annually thereafter.
The total study duration is anticipated to be approximately 5 years.