Rheos Feasibility Trial

Study Overview
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Brief Summary
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The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.

Official Title
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Rheos Feasibility Trial- A Study of Baroreflex Hypertension TherapyTM in Refractory Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Implantation of the Rheos System
* Other: Standard of care medical management


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rheos Device<br> | Device: Implantation of the Rheos System<br>* Open label<br>|
| Active Comparator: Medical Management<br> | Other: Standard of care medical management<br>* Patients will continue with medical therapy for standard of care of their hypertension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rheos Feasibility Study | To summarize the efficacy of the Rheos System by estimating the reduction of systolic blood pressure associated with activation of the Rheos System at 4 and 13 months post implant when compared to baseline (1-month post implant). To describe the safety of the Rheos System by summarizing all system related adverse events and estimating the serious sytem related event-free rate through 4 and 13 months post-implant. | 13 months |