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Recruiting
NCT02880618
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Conditions: Heart Failure
Sex: All
Healthy volunteers: No
Enrollment: 500
Sponsor: CVRx, Inc.
Location: Albertinen-Krankenhaus Hamburg Free and Hanseatic City of Hamburg
Summary
The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).
Eligibility Criteria
Inclusion Criteria:
* Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
* Subject has been implanted with the BAROSTIM NEO System in the past 30 days
* Subject has signed an Ethics Committee approved informed consent form
Exclusion Criteria:
* Bilateral carotid bifurcations located above the level of the mandible
* Baroreflex failure or autonomic neuropathy
* Uncontrolled, symptomatic cardiac bradyarrhythmias
* Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
* Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation
Source: ClinicalTrials.gov (NCT02880618). StuddyBuddy aggregates publicly available trial information.