Recruiting
BAROSTIM THERAPY™ In Resistant Hypertension
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.
ClinicalTrials.gov IDNCT02880631
PhaseNot Applicable
Enrollment500
SponsorCVRx, Inc.
AgeNot reported
SexALL
Conditions studied
Hypertension
About this study
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.
Interventions
- Device: BAROSTIM NEO™ System
Primary outcomes
- Blood Pressure Changes (Pre-implant baseline to 3 years post-implant)
- Cardiovascular Medication Changes (Post-implant enrollment to 3 years post-implant)
- Number of Health Care Utilizations (3 months post-implant to 3 years post-implant)
Eligibility information
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
Study locations
- Charité Benjamin Franklin, Berlin, 12203 Germany
- Charité Campus Virchow, Berlin, 13353 Germany
- Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau, 16321 Germany
- Cloppenburg Katholische Kliniken Münsterland, Cloppenburg, 49661 Germany
- Universitätsklinikum Köln Herzzentrum, Cologne, 50937 Germany
- Lippe Klinikum, Detmold, 32756 Germany
- Herzzentrum Dresden, Dresden, 01307 Germany
- Krankenhaus Erding, Erding, 85435 Germany
- Cardiovascular Center 'CVC' Frankfurt, Frankfurt, 60398 Germany
- Universitätsklinikum Gießen und Marburg, Giessen, 35392 Germany
Showing 10 of 26 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-23.