Rheos® Diastolic Heart Failure Trial

Rheos® Diastolic Heart Failure Trial

The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.

Inclusion Criteria:

• Be at least 21 years of age.
• Have bilateral carotid bifurcations that are below the level of the mandible.
• Have a left ventricular ejection fraction ≥ 45%.
• Clinical Heart Failure with elevated BNP or NT-Pro-BNP.

Exclusion Criteria:

• History of or suspected baroreflex failure or autonomic neuropathy.
• History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
• Organ or hematologic transplant.
• History of prior surgery, radiation, or stent placement in carotid sinus region.
• History of severe chronic kidney disease.
• Life expectancy to less than one year.