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Baroreflex Activation Therapy in Heart Failure

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ClinicalTrials.gov Identifier: NCT01484288
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : December 28, 2015
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Condition or disease Intervention/treatment
Heart Failure Device: Barostim Neo System

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Baroreflex Activation Therapy in Heart Failure
Study Start Date : November 2011
Primary Completion Date : July 2013
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Changes in sympathetic nervous system activity at 6 months from baseline [ Time Frame: baseline and 6 months ]

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

Inclusion Criteria:

  • Age at least 21 years
  • Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria:

  • Significant carotid plaque or stenosis
  • Known or suspected baroreflex failure or autonomic neuropathy
  • Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
  • Heart failure secondary to a reversible condition

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): NCT01484288

Milan, Italy
Sponsors and Collaborators
CVRx, Inc.
Principal Investigator: Edoardo G Gronda, MD, FESC MultiMedica

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01484288     History of Changes
Other Study ID Numbers: 360025
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases