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Therapeutic Areas: Pediatrics/Neonatology | Cardiology/Vascular Diseases
Disease Category: Hypertension (High Blood Pressure - Pediatric)

Trial Information

Rheos ™ Pivotal Trial

Sponsored by CVRx

A multi-center prospective clinical trial designed to demonstrate the efficacy and safety of the CVRx Rheos ™ Baroreflex Hypertension Therapy ™ System in patients with stage 2 hypertension that are resistant to treatment with at least three anti-hypertensive agents, one of which is a diuretic. This is the Pivotal trial supporting the Pre-market Approval application to the FDA for this device.

The Rheos Baroreflex Hypertension Therapy System consists of an implantable and programmable pulse generator, carotid sinus leads and a programmer system. The leads are permanently implanted on the perivascular area of the carotid sinus in proximity to the baroreceptors. This therapy uses electrical activation of the carotid sinus baroreflex to control blood pressure.

CAUTION: The Rheos System is an investigational device, and limited by USA law to investigational use.

Trial Design

• Randomized, blinded 12-month evaluation
• Target enrollment: 300 patients
• Follow-up continued until FDA approved
• Maximum number of trial sites: 40

Major Inclusion Criteria

• 21-80 years of age
• Have been assessed to have bilateral carotid bifurcations located at or below C3-C4
• Office cuff systolic blood pressure = 160 mmHg, diastolic blood pressure = 85 mmHg, and a 24 hour ambulatory systolic blood pressure = 150 mmHg despite at least 1 month of full therapy with at least 3 anti-hypertensive medications, one of which must be a diuretic
• Must be at least one year post bariatric surgery and at stable weight
• Must be certified by the investigator / hypertension specialist as compliant with taking full doses of medications
• Have signed a CVRx approved informed consent form for participation in this study

Major Exclusion Criteria

• BMI > 45 or arm circumference > 46cm
• Baroreflex failure or autonomic neuropathy
• Significant cardiac bradyarrhythmias
• Chronic atrial fibrillation
• Clinically significant cardiac valvular disease
• Hypertension secondary to a treatable cause other than sleep apnea
• Had an MI, CVA, unstable angina, or syncope within the past 3 months
• Solid organ or hemotologic transplant
• Chronic severe kidney disease defined by current of planned dialysis, or eGFR = 30 ml/min/ 1.73²
• Primary pulmonary hypertension, COPD, or reactive airway disease with a FEV1 < 1 L/min
• Prior surgery or radiation in either carotid sinus region
• Carotid atherosclerosis producing a =50% reduction in linear diameter or Grade C ulcerative plaques as determined by ultrasound or angiographic evaluation within 6 months of enrollment in the trial
• Pregnant or contemplating pregnancy during the follow up period

The Rheos Implantable Pulse Generator provides control and delivery of the activation energy through the Rheos Carotid Sinus leads. The leads are wrapped around the carotid sinus and conduct activation energy through the pulse generator to the left and right carotid sinus, which are the 2 main blood pressure control points. The Rheos Programmer System has the ability to communicate with the pulse generator.

The Rheos System takes advantage of the function of the body’s natural pressure sensors. It works by electrically activating the baroreflex. When the baroreflex is activated, it sends signals through neural pathways to the brain that are interpreted as a rise in blood pressure. The brain works to counteract this perceived rise in blood pressure by dilating the blood vessels, reducing the heart rate and influencing the kidneys to release fluid.

Rex Healthcare
4420 Lake Boone Trail
Raleigh, NC 27607
Phone: 919-784-3413
Fax: 919-784-3426
EMail: Kerry.Patterson@rexhealth.com

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