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Barostim HOPE4HF (Hope for Heart Failure) Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720160
First Posted: November 2, 2012
Last Update Posted: July 21, 2017
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 research study is to show whether the Neo system is safe and works in people with heart failure. The study is currently in long-term follow up.

Condition Intervention
Heart Failure Device: Barostim Neo system Other: Standard of care medical managment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ]
    To describe changes in measures compared to baseline.

  • System and procedure related adverse events [ Time Frame: 6 months ]
    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 2021
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.
  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 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
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): NCT01720160


  Show 23 Study Locations
Sponsors and Collaborators
CVRx, Inc.