BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction (HFrEF)

April 18, 2023 updated by: CVRx, Inc.

BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility:

Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure. The BAROSTIM NEO System is indicated for subjects with 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.

The contraindications are:

  • 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

Objectives:

To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:

  • New York Heart Association (NYHA) Class
  • Six Minute Hall Walk
  • Echocardiogram measures
  • Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).

Evaluate health care utilization over follow-up, such as heart failure hospitalizations.

Describe device programming and utilization

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Herzzentrum Bad Oyenhausen
        • Contact:
        • Principal Investigator:
          • Klaus-Jürgen Gutleben
      • Berlin, Germany, 12203
        • Active, not recruiting
        • Berlin Charité & Deutschen Herzzentrum Berlin
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Charite Campus Virchow Klinikum
      • Bernau, Germany, 16321
        • Active, not recruiting
        • Immanuel Klinikum Bernau Herzzentrum Brandenburg
      • Chemnitz, Germany, 09113
        • Active, not recruiting
        • Medizinisches Versorgungszentrum am Küchwald GmbH
      • Detmold, Germany, 32756
        • Active, not recruiting
        • Lippe Klinikum
      • Dresden, Germany, 01067
        • Active, not recruiting
        • Dresden Friedrichstadt
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Herzzentrum Dresden - Interventionelle Kardiologie
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Herzzentrum Dresden, Elektrophysiologie
      • Frankfurt, Germany, 60590
        • Active, not recruiting
        • Uniklinik Frankfurt
      • Gießen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Giessen und Marburg
      • Göttingen, Germany, 37075
        • Recruiting
        • Herzzentrum Gottingen
      • Hamburg, Germany, 22763
        • Active, not recruiting
        • Asklepios Klinik Altona
      • Hamburg, Germany, 22457
        • Active, not recruiting
        • Albertinen-Krankenhaus
      • Hamm, Germany, 59073
        • Active, not recruiting
        • St. Barbara Klinik Hamm
      • Hannover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
        • Principal Investigator:
          • Christian Veltmann
      • Ingolstadt, Germany, 85049
        • Active, not recruiting
        • Kardiologie im Klinikum Ingolstadt
      • Kiel, Germany, 24105
        • Active, not recruiting
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Köln, Germany, 50937
        • Active, not recruiting
        • Universitätsklinikum Köln Herzzentrum
      • Lahr, Germany, 77933
        • Active, not recruiting
        • Herzentrum Lahr
      • Leipzig, Germany, 04109
        • Active, not recruiting
        • Universitätsklinikum Leipzig
      • Leipzig, Germany, 04129
        • Recruiting
        • Leipzig St. Georg
        • Contact:
        • Principal Investigator:
          • Norbert Klein
      • Mainz, Germany, 55131
        • Active, not recruiting
        • Universitatsklinik Mainz
      • Münster, Germany, 48153
        • Active, not recruiting
        • Clemenshospital Münster
      • Paderborn, Germany, 33098
        • Active, not recruiting
        • St. Vincenz-Krankenhaus
      • Regensburg, Germany, 93053
        • Active, not recruiting
        • Universitätsklinikum Regensburg
      • Siegen, Germany, 57072
        • Active, not recruiting
        • Marienkrankenhaus Siegen
      • Stadtlohn, Germany, 48970
        • Active, not recruiting
        • Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
      • Tuttlingen, Germany, 78532
        • Recruiting
        • Klinikum Tuttlingen
  • Italy
      • Campobasso, Italy, 86100
        • Active, not recruiting
        • Fondazione di Ricerca e Cura "Giovanni Paolo II"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Study Chair: Jochen Müller-Ehmsen, PhD, Asklepios Klinik Altona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2016

Primary Completion (Anticipated)

July 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360049-001

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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