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Device Based Therapy in Hypertension Trial | Clinical Trials | Clareo Health

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Device Based Therapy in Hypertension Trial

A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

NCT00710190•CVRx, Inc.

Summary

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

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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

University Hospital Hannover

Hanover, Germany

Latvian Centre of Cardiology

Riga, Latvia

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Medical University of Gdansk

Gdansk, Poland

Inselspital Bern

Bern, Switzerland

Key Dates

Start Date

July 1, 2003

Primary Completion Date

October 1, 2011

Completion Date

October 1, 2011

Last Updated

October 21, 2016

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

Rheos Baroreflex Hypertension Therapy System

DEVICE

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Device Based Therapy in Hypertension Trial

Inclusion Criteria

Exclusion Criteria

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