Device Based Therapy in Hypertension Trial

CVRx, Inc.46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Rheos Baroreflex Hypertension Therapy SystemDEVICE

This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (9)

University Hospital Hradec Kralove

Hradec Králové, Czechia

University Hospital Bad Oeynhausen

Bad Oeynhausen, Germany

Charité Campus Buch

Berlin, Germany

Uniklinik Essen

Essen, Germany

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 months post implant

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.