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Barostim HOPE4HF (Hope for Heart Failure) Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
CVRx, Inc. Identifier:
First received: October 29, 2012
Last updated: October 17, 2016
Last verified: October 2016
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
Other: Standard of care medical managment

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.

Enrollment: 98
Study Start Date: November 2012
Estimated Study Completion Date: January 2017
Primary Completion Date: May 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
Active Comparator: Medical Management Group
Medical management therapy only
Other: Standard of care medical managment
Other Name: Patients will continue with medical therapy for standard of care of their heart failure condition

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01720160

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Sponsors and Collaborators
CVRx, Inc.