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
- Bad Oeynhausen, Berlin, Bernau, Chemnitz, Cologne, Detmold, Dresden, Frankfurt, Giessen, Göttingen, Hamburg, Hamm, Hanover, Ingolstadt, Kiel, Lahr, Leipzig, Mainz, Münster, Paderborn, Regensburg, Siegen, Stadtlohn, and Tuttlingen, GermanySee the 29 sites
Where in Germany
- Herzzentrum Bad OyenhausenBad Oeynhausen, GermanyTaking people
- Berlin Charité & Deutschen Herzzentrum BerlinBerlin, GermanyNo longer taking part
- Charité Campus Virchow-KlinikumBerlin, GermanyNo longer taking part
- Immanuel Klinikum Bernau Herzzentrum BrandenburgBernau, GermanyNo longer taking part
- Medizinisches Versorgungszentrum am Küchwald GmbHChemnitz, GermanyNo longer taking part
- Universitätsklinikum Köln HerzzentrumCologne, GermanyNo longer taking part
- Lippe KlinikumDetmold, GermanyNo longer taking part
- Dresden FriedrichstadtDresden, GermanyNo longer taking part
- Herzzentrum Dresden - Interventionelle KardiologieDresden, GermanyNo longer taking part
- Herzzentrum Dresden, ElektrophysiologieDresden, GermanyNo longer taking part
- Uniklinik FrankfurtFrankfurt, GermanyNo longer taking part
- Universitätsklinikum Gießen und MarburgGiessen, GermanyTaking people
- Herzzentrum GöttingenGöttingen, GermanyNo longer taking part
- Albertinen-KrankenhausHamburg, GermanyNo longer taking part
- Asklepios Klinik AltonaHamburg, GermanyNo longer taking part
- St. Barbara-Klinik HammHamm, GermanyNo longer taking part
- Medizinische Hochschule HannoverHanover, GermanyTaking people
- Kardiologie im Klinikum IngolstadtIngolstadt, GermanyNo longer taking part
- Universitätsklinikum Schleswig-Holstein, Campus KielKiel, GermanyNo longer taking part
- Herzentrum LahrLahr, GermanyNo longer taking part
- Leipzig St. GeorgLeipzig, GermanyTaking people
- Universitatsklinikum LeipzigLeipzig, GermanyNo longer taking part
- Universitätsklinik MainzMainz, GermanyNo longer taking part
- Clemenshospital MünsterMünster, GermanyNo longer taking part
- St. Vincenz-KrankenhausPaderborn, GermanyNo longer taking part
- Universitätsklinikum RegensburgRegensburg, GermanyNo longer taking part
- Marienkrankenhaus SiegenSiegen, GermanyNo longer taking part
- Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbHStadtlohn, GermanyNo longer taking part
- Klinikum TuttlingenTuttlingen, GermanyTaking people
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.