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Barostim HOPE4HF (Hope for Heart Failure) Study

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ClinicalTrials.gov Identifier: NCT01720160
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Device: Barostim Neo system Other: Standard of care medical managment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barostim HOPE4HF Study
Study Start Date : November 2012
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Heart failure metric improvements from baseline [ Time Frame: 12 months ]
    To describe changes in measures compared to baseline.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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.

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.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01720160     History of Changes
Other Study ID Numbers: 360032
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases