Effect of the MobiusHD® in Patients With Heart Failure

Summary

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.

Eligibility

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) per country 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 intracranial bleed 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 determined by carotid duplex
9. Internal ICA lumen diameters \<5.0 mm or \>11.75 mm within the planned location of the implant placement, or evidence of landing zone restrictions, such as inadequate length, vessel tapering, and/or vessel curvature that would preclude safe placement of the implant

Conditions2

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