Follows people with heart failure who received the Barostim Neo device
Studies a device, Barostim Neo, in adults with reduced-function heart failure.
Plain-language title generated from the registry record
Registry title: BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Key facts
- Where
- Campobasso, ItalySee the site
Where in Italy
- Fondazione di Ricerca e Cura "Giovanni Paolo II"Campobasso, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- CVRx, Inc.
- Trial code
- NCT02880618
- Record updated
- 11 September 2026
- Original description
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).Read full original descriptionShow less
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
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).
Inclusion: 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: Baroreflex failure or autonomic neuropathy; Uncontrolled, symptomatic cardiac bradyarrhythmias; Bilateral carotid bifurcations located above the level of the mandible; 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.