Impact of Barostimulation on Hemodynamics in Adults With Heart Failure

Prior treatment

• Current treatment with inotropes
• Prior surgery, radiation, endovascular stent in the carotid sinus
• History or consideration of solid organ transplantation

Other illness

• Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening
• Baroreflex failure or autonomic neuropathy
• Severe chronic lung disease
• Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening
• Non-cardiovascular conditions interfering with 6MWT distance assessment
• Known allergy to silicone or titanium

Age

• Age \< 18 years

Other

• Bilateral carotid bifurcations located above the level of the mandible
• Carotid artery stenosis greater than 50% caused by atherosclerosis
• Ulcerative plaques in the carotid artery
• Symptomatic un-controlled bradyarrhythmias
• Pacemaker or ICD within 3 months of screening
• History or consideration of left ventricular assist device (LVAD)
• Life expectancy \<1 year from time of screening
• Inability to fulfill protocol requirements

• Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)
• Symptoms consistent with one of:
  • current New York Heart Association (NYHA) Class III or
  • current NYHA Class II and historical NYHA Class III
• Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \< 1600 pg/ml (should be within 3 months of screen)
• Management with maximally-tolerated GDMT medications and devices
• Age \>= 18 years