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Device Based Therapy in Hypertension Trial (DEBuT-HT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710190
First Posted: July 4, 2008
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CVRx, Inc.
  Purpose
The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Condition Intervention
Hypertension Device: Rheos Baroreflex Hypertension Therapy System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 46
Study Start Date: July 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rheos Implant Device: Rheos Baroreflex Hypertension Therapy System
This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710190


Locations
Czech Republic
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic
Germany
University Hospital Bad Oeynhausen
Bad Oeynhausen, Germany
Charité Campus Buch
Berlin, Germany
Uniklinik Essen
Essen, Germany
University Hospital Hannover
Hannover, Germany
Latvia
Latvian Centre of Cardiology
Riga, Latvia
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Poland
Medical University of Gdansk
Gdansk, Poland
Switzerland
Inselspital Bern
Bern, Switzerland
Sponsors and Collaborators
CVRx, Inc.
Investigators
Study Director: Thomas Baal, PhD CVRx, Inc.
  More Information

Additional Information:
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00710190     History of Changes
Other Study ID Numbers: 360004-001
First Submitted: July 1, 2008
First Posted: July 4, 2008
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by CVRx, Inc.:
Drug Resistant Hypertension
Refractory Hypertension
High Blood Pressure
Baroreflex Hypertension Therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases