Baroreflex Activation Therapy in Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01484288
First received: November 29, 2011
Last updated: April 11, 2014
Last verified: April 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (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 and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01484288

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

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01484288     History of Changes
Other Study ID Numbers: 360025
Study First Received: November 29, 2011
Last Updated: April 11, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014