BAROSTIM THERAPY™ In Resistant Hypertension
Recruiting · NCT02880631 · 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 (NCT02880631) 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 resistant hypertension.
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
- Has signed an EC approved informed consent form
- Has been implanted with the BAROSTIM NEO system in the past 30 days
- Systolic blood pressure greater than or equal to 140 mmHg, and
- Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications
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
26 locations listed.
- Charité Benjamin Franklin - Berlin, Germany
- Charité Campus Virchow - Berlin, Germany
- Immanuel Klinikum Bernau Herzzentrum Brandenburg - Bernau, Germany
- Cloppenburg Katholische Kliniken Münsterland - Cloppenburg, Germany
- Universitätsklinikum Köln Herzzentrum - Cologne, Germany
- Lippe Klinikum - Detmold, Germany
- Herzzentrum Dresden - Dresden, Germany
- Krankenhaus Erding - Erding, Germany
- Cardiovascular Center 'CVC' Frankfurt - Frankfurt, Germany
- Universitätsklinikum Gießen und Marburg - Giessen, Germany
- Herzzentrum Göttingen - Göttingen, Germany
- Asklepios Klinik Altona - Hamburg, Germany
- St. Barbara Klinik Hamm - Hamm, Germany
- Kardiologie im Klinikum Ingolstadt - Ingolstadt, Germany
- Universitätsklinikum Schleswig-Holstein Campus Kiel - Kiel, Germany
- Herzentrum Lahr - Lahr, Germany
- Universitätsklinikum Leipzig - Leipzig, Germany
- Maastricht University Medical Center - Maastricht, Netherlands
- Universitätsklinik Mainz - Mainz, Germany
- Papenburg Marien Krankenhaus - Papenburg, Germany
- Universitätsklinikum Regensburg - Regensburg, Germany
- Marienkrankenhaus Siegen - Siegen, Germany
- Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH - Stadtlohn, Germany
- Klinikum Stuttgart - Stuttgart, Germany
- Klinikum Tuttlingen - Tuttlingen, Germany
- Heinrich-Braun Klinikum - Zwickau, Germany