Barostim HOPE4HF (Hope for Heart Failure) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01720160
First received: October 29, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

The purpose of this research study is to show whether the Neo system is safe and works in people with heart failure.


Condition Intervention
Heart Failure
Device: Barostim Neo system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Barostim HOPE4HF Study

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Heart failure metric improvements from baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To describe changes in measures compared to baseline.

  • System and procedure related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To demonstrate the safety of the Neo system in a heart failure population.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Group
Barostim Neo system
Device: Barostim Neo system
Patients will be implanted with the Neo system.
Other Name: Neo system
No Intervention: Medical Management Group
Medical management therapy only

Detailed Description:

A prospective, randomized study describing the safety and efficacy of the Neo system in approximately 60 heart failure subjects with a left ventricular ejection fraction equal or less than 35 percent.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 21 years or above.
  • On optimal, guideline-directed (per the American Heart Association/American College of Cardiology guidelines), stable, heart-failure medications and dose for at least 4 weeks prior to screening.

Exclusion Criteria:

  • Known or suspected baroreflex failure or autonomic neuropathy.
  • Myocardial infarction, unstable angina, syncope, cerebral vascular accident, sudden cardiac death (SCD), or received defibrillation therapy within 3 months.
  • Heart failure secondary to a reversible cause or treatable condition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720160

  Show 21 Study Locations
Sponsors and Collaborators
CVRx, Inc.
  More Information

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01720160     History of Changes
Other Study ID Numbers: 360032
Study First Received: October 29, 2012
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014