Trial record 1 of 1 for:    NCT01720160
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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
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: 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
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 20, 2014