BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

NCT02880618 · 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

Heart Failure

Investigational drug(s) / intervention(s)

Barostim Neo™ System

Study summary

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).

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Change in New York Heart Association Functional Classification at 6 months Post-Implant — Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant — Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant — Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) — Baseline, 6 months post-implant
To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
Number of Hospitalizations over Follow-Up — 12 months post-implant
To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.

Trial sites (30)

Facility	City	Region	Status
Albertinen-Krankenhaus	Hamburg	Free and Hanseatic City of Hamburg	Active Not Recruiting
Herzzentrum Bad Oyenhausen	Bad Oeynhausen	Germany	Recruiting
Berlin Charité & Deutschen Herzzentrum Berlin	Berlin	Germany	Active Not Recruiting
Charité Campus Virchow Klinikum	Berlin	Germany	Active Not Recruiting
Immanuel Klinikum Bernau Herzzentrum Brandenburg	Bernau	Germany	Active Not Recruiting
Medizinisches Versorgungszentrum am Küchwald GmbH	Chemnitz	Germany	Active Not Recruiting
Universitätsklinikum Köln Herzzentrum	Cologne	Germany	Active Not Recruiting
Lippe Klinikum	Detmold	Germany	Active Not Recruiting
Dresden Friedrichstadt	Dresden	Germany	Active Not Recruiting
Herzzentrum Dresden - Interventionelle Kardiologie	Dresden	Germany	Active Not Recruiting
Herzzentrum Dresden, Elektrophysiologie	Dresden	Germany	Active Not Recruiting
Uniklinik Frankfurt	Frankfurt	Germany	Active Not Recruiting
Universitätsklinikum Gießen und Marburg	Giessen	Germany	Recruiting
Herzzentrum Göttingen	Göttingen	Germany	Terminated
Asklepios Klinik Altona	Hamburg	Germany	Active Not Recruiting
St. Barbara Klinik Hamm	Hamm	Germany	Active Not Recruiting
Medizinische Hochschule Hannover	Hanover	Germany	Recruiting
Kardiologie im Klinikum Ingolstadt	Ingolstadt	Germany	Active Not Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel	Germany	Active Not Recruiting
Herzentrum Lahr	Lahr	Germany	Active Not Recruiting
Universitätsklinikum Leipzig	Leipzig	Germany	Active Not Recruiting
Leipzig St. Georg	Leipzig	Germany	Recruiting
Universitätsklinik Mainz	Mainz	Germany	Active Not Recruiting
Clemenshospital Münster	Münster	Germany	Active Not Recruiting
St. Vincenz-Krankenhaus	Paderborn	Germany	Active Not Recruiting
Universitätsklinikum Regensburg	Regensburg	Germany	Active Not Recruiting
Marienkrankenhaus Siegen	Siegen	Germany	Active Not Recruiting
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH	Stadtlohn	Germany	Active Not Recruiting
Klinikum Tuttlingen	Tuttlingen	Germany	Recruiting
Fondazione di Ricerca e Cura "Giovanni Paolo II"	Campobasso	Italy	Active Not Recruiting

More CVRx, Inc. trials in Germany

BAROSTIM THERAPY™ In Resistant Hypertension 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

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients Recruiting

Effects of Negative Pressure Ventilation Onto Hemodynamics and Right Ventricular Funktion in Patients After Implantation of a Left Ventricular Assist Device. Recruiting

Voice Analysis to Detect Pulmonary Arterial Pressure Changes in Heart Failure Recruiting

Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting

The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R) 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 NCT02880618 on ClinicalTrials.gov ↗ ← All trials in Germany