Status:
COMPLETED
Baroreflex Activation Therapy in Heart Failure
Lead Sponsor:
CVRx, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- Age at least 21 years
- Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01484288
Start Date
November 1 2011
End Date
March 1 2015
Last Update
August 26 2021
Active Locations (1)
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1
MultiMedica
Milan, Italy