BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
Recruiting · NCT02880618 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Barostim Neo™ System
What this trial is about
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).
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
30 locations listed.
- Herzzentrum Bad Oyenhausen - Bad Oeynhausen, Germany
- Berlin Charité & Deutschen Herzzentrum Berlin - Berlin, Germany
- Charité Campus Virchow Klinikum - Berlin, Germany
- Immanuel Klinikum Bernau Herzzentrum Brandenburg - Bernau, Germany
- Fondazione di Ricerca e Cura "Giovanni Paolo II" - Campobasso, Italy
- Medizinisches Versorgungszentrum am Küchwald GmbH - Chemnitz, Germany
- Universitätsklinikum Köln Herzzentrum - Cologne, Germany
- Lippe Klinikum - Detmold, Germany
- Dresden Friedrichstadt - Dresden, Germany
- Herzzentrum Dresden - Interventionelle Kardiologie - Dresden, Germany
- Herzzentrum Dresden, Elektrophysiologie - Dresden, Germany
- Uniklinik Frankfurt - Frankfurt, Germany
- Universitätsklinikum Gießen und Marburg - Giessen, Germany
- Herzzentrum Göttingen - Göttingen, Germany
- Asklepios Klinik Altona - Hamburg, Germany
- St. Barbara Klinik Hamm - Hamm, Germany
- Medizinische Hochschule Hannover - Hanover, Germany
- Kardiologie im Klinikum Ingolstadt - Ingolstadt, Germany
- Universitätsklinikum Schleswig-Holstein Campus Kiel - Kiel, Germany
- Herzentrum Lahr - Lahr, Germany
- Universitätsklinikum Leipzig - Leipzig, Germany
- Leipzig St. Georg - Leipzig, Germany
- Universitätsklinik Mainz - Mainz, Germany
- Clemenshospital Münster - Münster, Germany
- St. Vincenz-Krankenhaus - Paderborn, Germany
- Universitätsklinikum Regensburg - Regensburg, Germany
- Marienkrankenhaus Siegen - Siegen, Germany
- Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH - Stadtlohn, Germany
- Klinikum Tuttlingen - Tuttlingen, Germany
- Albertinen-Krankenhaus - Hamburg, Free and Hanseatic City of Hamburg, Germany