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Barostim Neo System in the Treatment of Heart Failure
Overall Recruitment Status: Active, enrollment completed
Official Title
Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure
Region Sponsors
California - Southern
CVRx, Inc.
Acronym KP IRB No.
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
Study Population Description
Individuals with Heart Failure
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.
Detailed Description
The Barostim Neo - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure
Gender Age Limit
Male & Female
Inclusion Criteria
  • Age at least 21 years
  • Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
Exclusion Criteria
  • Significant carotid plaque or stenosis
  • Known or suspected baroreflex failure or autonomic neuropathy
  • Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
  • Heart failure secondary to a reversible condition

Keywords and/or Specific Medical Conditions
  • Cardiovascular Diseases
  • Heart Failure
  • Heart Diseases
  • Cardiology
KP Clinical Facility
  • Los Angeles (Sunset)
Clinical Area
  • Cardiology

Principal Investigator:
Nigel Gupta, MD
Contact Information:
- Kaiser Permanente Clinical Trials
-Southern California

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