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Barostim Neo System in the Treatment of Resistant Hypertension

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
CVRx, Inc. Identifier:
First received: November 9, 2011
Last updated: October 19, 2016
Last verified: October 2016
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 Intervention
High Blood Pressure
Device: Barostim Neo System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neo Non-Randomized Hypertension Study

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Change from baseline in Systolic Blood Pressure at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: August 2026
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01471834

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
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
Maastricht University
Maastricht, Netherlands, HX6229
Sponsors and Collaborators
CVRx, Inc.
Principal Investigator: Hermann Haller, MD Hannover Medical School
  More Information

Responsible Party: CVRx, Inc. Identifier: NCT01471834     History of Changes
Other Study ID Numbers: 360016 
Study First Received: November 9, 2011
Last Updated: October 19, 2016
Health Authority: Canada: Health Canada
Netherlands: Medicines Evaluation Board (MEB)
Germany: Federal Insitute for Drugs and Medical Devices

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on October 21, 2016