NCT02880618Recruiting
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 15 Aug 2016
- Start date
- 13 Dec 2016
- Primary completion date
- Jul 2027
- Lead sponsor
- CVRx, Inc.
- Diseases
- Heart failure
- NCT number
- NCT02880618
What you commit to
- Study type: Observational
- Planned participants: 500
- From 13 Dec 2016 to the primary completion date, Jul 2027
- 30 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Baroreflex failure or autonomic neuropathy
- Uncontrolled, symptomatic cardiac bradyarrhythmias
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herzzentrum Bad Oyenhausen Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Recruiting |
| Berlin Charité & Deutschen Herzzentrum Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Charité Campus Virchow-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Immanuel Klinikum Bernau Herzzentrum Brandenburg Coordinator of this site? Confirm its status | Bernau | Germany | Active, not recruiting |
| Medizinisches Versorgungszentrum am Küchwald GmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Active, not recruiting |
| Universitätsklinikum Köln Herzzentrum Coordinator of this site? Confirm its status | Cologne | Germany | Active, not recruiting |
| Lippe Klinikum Coordinator of this site? Confirm its status | Detmold | Germany | Active, not recruiting |
| Herzzentrum Dresden - Interventionelle Kardiologie Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Dresden Friedrichstadt Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Herzzentrum Dresden, Elektrophysiologie Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Uniklinik Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Active, not recruiting |
| Universitätsklinikum Gießen und Marburg Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Herzzentrum Göttingen Coordinator of this site? Confirm its status | Göttingen | Germany | Terminated |
| Albertinen-Krankenhaus Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Asklepios Klinik Altona Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| St. Barbara-Klinik Hamm Coordinator of this site? Confirm its status | Hamm | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Kardiologie im Klinikum Ingolstadt Coordinator of this site? Confirm its status | Ingolstadt | Germany | Active, not recruiting |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Herzentrum Lahr Coordinator of this site? Confirm its status | Lahr | Germany | Active, not recruiting |
| Leipzig St. Georg Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Universitätsklinik Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Active, not recruiting |
| Clemenshospital Münster Coordinator of this site? Confirm its status | Münster | Germany | Active, not recruiting |
| St. Vincenz-Krankenhaus Coordinator of this site? Confirm its status | Paderborn | Germany | Active, not recruiting |
| Universitätsklinikum Regensburg Coordinator of this site? Confirm its status | Regensburg | Germany | Active, not recruiting |
| Marienkrankenhaus Siegen Coordinator of this site? Confirm its status | Siegen | Germany | Active, not recruiting |
| Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH Coordinator of this site? Confirm its status | Stadtlohn | Germany | Active, not recruiting |
| Klinikum Tuttlingen Coordinator of this site? Confirm its status | Tuttlingen | Germany | Recruiting |
| Fondazione di Ricerca e Cura "Giovanni Paolo II" Coordinator of this site? Confirm its status | Campobasso | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.