Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection Fraction (EF) ≥ 40%) Trial

This study closed to enrollment before adequate endpoint data was collected and before
enrollment was completed. The study was not stopped for safety or futility, but for
business/strategic reasons due to production of a new generation of the device. Currently,
subjects are still enrolled in the trial under long-term follow-up.

Inclusion Criteria:

- At least 21 years of age

- Have bilateral carotid bifurcations that are below the level of the mandible

- Have a left ventricular ejection fraction ≥ 40%

- Symptomatic heart failure with elevated blood pressure

- Elevated brain natriuretic peptide (BNP) or n-terminal pro-brain natriuretic peptide
(NT-proBNP)

- Serum creatine ≤ 2.5 mg/dL and not being treated with dialysis

Exclusion Criteria:

- Known or suspected baroreflex failure or autonomic neuropathy

- History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative
cardiomyopathy, or primary hypertrophic cardiomyopathy

- Solid organ or hematologic transplant

- History of prior surgery, radiation, or stent placement in carotid sinus region

- Life expectancy of less than one year for non-cardiovascular reasons