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Baroreflex Activation Therapy in Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01484288
First Posted: December 2, 2011
Last Update Posted: December 28, 2015
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 clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Condition Intervention
Heart Failure Device: Barostim Neo System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Baroreflex Activation Therapy in Heart Failure

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

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

Enrollment: 12
Study Start Date: November 2011
Study Completion Date: March 2015
Primary Completion Date: July 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  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): NCT01484288


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

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01484288     History of Changes
Other Study ID Numbers: 360025
First Submitted: November 29, 2011
First Posted: December 2, 2011
Last Update Posted: December 28, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases