BAROSTIM THERAPY™ In Resistant Hypertension

NCT02880631 · tracked via the Priya Life Science Germany tracker

Sponsor

CVRx, Inc

Phase

Observational

Started

2016-12-13

Last updated

2026-09-11

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

BAROSTIM NEO™ System

Study summary

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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Blood Pressure Changes — Pre-implant baseline to 3 years post-implant
The results of an office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Cardiovascular Medication Changes — Post-implant enrollment to 3 years post-implant
Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Number of Health Care Utilizations — 3 months post-implant to 3 years post-implant
Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.

Trial sites (26)

Facility	City	Region	Status
Charité Benjamin Franklin	Berlin	Germany	Active Not Recruiting
Charité Campus Virchow	Berlin	Germany	Active Not Recruiting
Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau	Germany	Recruiting
Cloppenburg Katholische Kliniken Münsterland	Cloppenburg	Germany	Active Not Recruiting
Universitätsklinikum Köln Herzzentrum	Cologne	Germany	Recruiting
Lippe Klinikum	Detmold	Germany	Recruiting
Herzzentrum Dresden	Dresden	Germany	Recruiting
Krankenhaus Erding	Erding	Germany	Active Not Recruiting
Cardiovascular Center 'CVC' Frankfurt	Frankfurt	Germany	Recruiting
Universitätsklinikum Gießen und Marburg	Giessen	Germany	Recruiting
Herzzentrum Göttingen	Göttingen	Germany	Recruiting
Asklepios Klinik Altona	Hamburg	Germany	Recruiting
St. Barbara Klinik Hamm	Hamm	Germany	Active Not Recruiting
Kardiologie im Klinikum Ingolstadt	Ingolstadt	Germany	Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel	Germany	Recruiting
Herzentrum Lahr	Lahr	Germany	Active Not Recruiting
Universitätsklinikum Leipzig	Leipzig	Germany	Recruiting
Universitätsklinik Mainz	Mainz	Germany	Active Not Recruiting
Papenburg Marien Krankenhaus	Papenburg	Germany	Active Not Recruiting
Universitätsklinikum Regensburg	Regensburg	Germany	Recruiting
Marienkrankenhaus Siegen	Siegen	Germany	Recruiting
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH	Stadtlohn	Germany	Active Not Recruiting
Klinikum Stuttgart	Stuttgart	Germany	Recruiting
Klinikum Tuttlingen	Tuttlingen	Germany	Recruiting
Heinrich-Braun Klinikum	Zwickau	Germany	Active Not Recruiting
Maastricht University Medical Center	Maastricht	Netherlands	Active Not Recruiting

More CVRx, Inc. trials in Germany

BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction Recruiting

Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension Active, not recruiting

Other trials for the same condition

Effectiveness of a Digital Health Application for Primary Hypertension (Liebria) Active, not recruiting

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT Recruiting

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting

Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension Recruiting

WB-EMS Effects on Cardiometabolic Risk Factors Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02880631 on ClinicalTrials.gov ↗ ← All trials in Germany