Device Based Therapy in Hypertension Trial

The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.

Inclusion criteria

• Be at least 21 years of age.
• Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
• Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months 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 as compliant to taking full doses of medications.
• Have signed an approved informed consent form for participation in this study.

Exclusion criteria

• Have been diagnosed with:

• Baroreflex failure or significant orthostatic hypotension
• Cardiac brady arrhythmias or chronic atrial fibrillation
• Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
• 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 4-month follow-up period.
• Are on dialysis
• Have hypertension secondary to a treatable cause
• Have clinically significant cardiac valvular disease
• Are unable to comply with protocol requirements.
• Are unlikely to survive the protocol follow-up period
• Are enrolled in another concurrent clinical trial