Rheos Feasibility Trial

Inclusion criteria

• Be at least 21 years of age.
• Have been assessed to have bilateral carotid bifurcations located at or below C3-C4.
• Have an office cuff systolic blood pressure greater than or equal to 160 mmHg and a 24-hour ambulatory systolic blood pressure greater than or equal to 150 mmHg despite at least one month of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
• Must be certified by the investigator hypertension specialist as compliant with taking full doses of medication.
• Have signed a CVRx approved informed consent for participation in this study.

Exclusion criteria

• Have been diagnosed with:

• Baroreflex failure
• Cardiac bradyarrhythmias
• Chronic atrial fibrillation
• Had a heart transplant
• Have carotid atherosclerosis producing a 50% or greater reduction in linear diameter as determined by ultrasound or angiographic evaluation as determined within six months of enrollment in the trial.
• Have Grade C ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation.
• Have prior surgery or radiation in either carotid sinus region.
• Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
• Are pregnant or contemplating pregnancy during the 13-month follow-up period.
• Currently undergoing dialysis.
• Have hypertension secondary to a treatable cause.
• Have clinically significant cardiac valvular disease.
• Are unable or unwilling to fulfill the protocol medication compliance and follow-up requirements.
• Are unlikely to survive the protocol follow-up period.
• Are enrolled in another concurrent clinical trial.

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