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Barostim Neo System in the Treatment of Resistant Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01471834
First received: November 9, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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: July 2015
Estimated Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471834

Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Hermann Haller, MD Hannover Medical School
  More Information

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01471834     History of Changes
Other Study ID Numbers: 360016
Study First Received: November 9, 2011
Last Updated: October 29, 2012
Health Authority: Canada: Health Canada
Netherlands: Medicines Evaluation Board (MEB)
Germany: Federal Insitute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013