Effect of the MobiusHD® in Patients With Heart Failure

Inclusion Criteria:

1. Age 18 years or above
2. Currently NYHA Class II, III or ambulatory IV heart failure
3. Left ventricular ejection fraction ≤ 40%
4. NT-proBNP ≥ 400
5. Prescribed optimally-tolerated, stable, Guideline Directed Medical Therapy (GDMT) percountry specific guidelines for the treatment of heart failure for at least 4 weeks
6. Six-minute hall walk (6MHW) distance of ≥ 150 m AND ≤ 400 m
7. Deemed an acceptable candidate for the implant procedure by the investigator

Exclusion Criteria:

1. Known or clinically suspected baroreflex failure or autonomic neuropathy
2. Currently implanted with a barostimulator device
3. Received cardiac resynchronization therapy (CRT) within six months of implantation
4. Received a CardioMEMS device within three months of the screening visit
5. History of any prior stroke with permanent neurologic defect or any prior intracranialbleed or other serious brain injury
6. Body mass index > 45
7. Serum estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
8. Presence of atherosclerotic plaque in the intended side for implantation as determinedby carotid duplex
9. Internal ICA lumen diameters <5.0 mm or >11.75 mm within the planned location of theimplant placement, or evidence of landing zone restrictions, such as inadequatelength, vessel tapering, and/or vessel curvature that would preclude safe placement ofthe implant