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Barostim Neo System in the Treatment of Resistant Hypertension

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.
ClinicalTrials.gov Identifier: NCT01471834
Recruitment Status : Active, not recruiting
First Posted : November 16, 2011
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx Barostim Neo System in the treatment of resistant hypertension.

Condition or disease Intervention/treatment
High Blood Pressure Device: Barostim Neo System

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo Non-Randomized Hypertension Study
Study Start Date : June 2011
Primary Completion Date : May 2012
Estimated Study Completion Date : August 2026
Arms and Interventions

Arm Intervention/treatment
Experimental: Device group
Barostim Neo System
Device: Barostim Neo System
Baroreflex Activation Therapy using the Barostim Neo System
Other Names:
  • XR-1 system
  • Neo system


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in Systolic Blood Pressure at 6 months. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 21 years and no more than 80 years
  • Resistant hypertension despite optimal, stable antihypertensive medications for at least 4 weeks

Exclusion Criteria:

  • Significant carotid plaque or stenosis
  • Known or suspected baroreflex failure or autonomic neuropathy
  • Significant renal disease requiring dialysis
  • Myocardial infarction, unstable angina, syncope, or cerebral vascular accident within the past 3 months
  • Secondary hypertension
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): NCT01471834


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
University of Alberta - Edmonton
Edmonton, Alberta, Canada, T2P 1C4
Canada, Ontario
London-Lawson Health Research Institute
London, Ontario, Canada, N6A 5A5
Germany
University Hospital Cologne
Cologn, Germany, 50924
University Hospital Duesseldorf
Duesseldorf, Germany, 40225
Goettingen-Georg August University
Goettingen, Germany, 37075
Midizinische Hochschule Hannover
Hannover, Germany, 30625
Klinkum St. George Leipzig
Leipzig, Germany, 04129
Netherlands
Maastricht University
Maastricht, Netherlands, HX6229
Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Hermann Haller, MD Hannover Medical School
More Information

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01471834     History of Changes
Other Study ID Numbers: 360016
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases