Device Based Therapy in Hypertension Trial

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Detailed Description
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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.

Official Title
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A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Rheos Baroreflex Hypertension Therapy System


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 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

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rheos Implant<br> | Device: Rheos Baroreflex Hypertension Therapy System<br>* This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate. |  | 4 months post implant | 
| Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy. |  | 4 months post implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Resistant Hypertension, Refractory Hypertension, High Blood Pressure, Baroreflex Hypertension Therapy