BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction (HFpEF)

September 9, 2026 updated by: CVRx, Inc.

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

The purpose of this registry (NCT02876042) 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 that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility Criteria:

The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:

  • Indications

    • 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

  • Contraindications

    • 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 Type

Observational

Enrollment (Actual)

11

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Berlin Charité & Deutschen Herzzentrum Berlin
      • Bernau, Germany, 16321
        • Immanuel Klinikum Bernau Herzzentrum Brandenburg
      • Cologne, Germany, 50937
        • Universitätsklinikum Köln Herzzentrum
      • Detmold, Germany, 32756
        • Lippe Klinikum
      • Frankfurt, Germany, 60590
        • Uniklinik Frankfurt
      • Giessen, Germany, 35392
        • Universitätsklinikum Giessen und Marburg
      • Göttingen, Germany, 37075
        • Herzzentrum Göttingen
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg
      • Ingolstadt, Germany, 85049
        • Kardiologie im Klinikum Ingolstadt
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Siegen, Germany, 57072
        • Marienkrankenhaus Siegen

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

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria.

Description

Inclusion Criteria:

  • Sign an Ethics Committee (EC) approved informed consent form for the registry.
  • Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.
  • BAROSTIM THERAPY not yet chronically activated.
  • Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.
  • On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.

  • Objective evidence of heart failure according to the following criteria:

    • Hospitalization for heart failure within 12 months prior to enrollment OR
    • Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 30 days prior to enrollment OR
    • NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 30 days prior to enrollment

Exclusion Criteria:

  • Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
  • Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

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
Changes in Office Cuff Systolic Blood Pressure
Time Frame: Pre-implant baseline to 6 months post-implant
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), and at 3 and 6 months post-implant.
Pre-implant baseline to 6 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in New York Heart Association Functional Classification
Time Frame: Pre-implant baseline to 6 months post-implant
New York Heart Association Classification, if available, should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.
Pre-implant baseline to 6 months post-implant
Changes in Left Ventricular Mass Index
Time Frame: Pre-implant baseline to 6 months post-implant
An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.
Pre-implant baseline to 6 months post-implant
Changes in LA volume index
Time Frame: Pre-implant baseline to 6 months post-implant
An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.
Pre-implant baseline to 6 months post-implant
Changes in E/E' ratio
Time Frame: Pre-implant baseline to 6 months post-implant
An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.
Pre-implant baseline to 6 months post-implant
Changes in NT-proBNP
Time Frame: Pre-implant baseline, 6 months post-implant
If available, measurement should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.
Pre-implant baseline, 6 months post-implant
Evaluate health care utilization over follow-up, such as heart failure hospitalizations
Time Frame: Pre-implant baseline to 6 months post-implant
Health care utilization information is collected throughout follow-up.
Pre-implant baseline to 6 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: Burkert Pieske, PhD, Universitätmedizin Berlin - Charité

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

Helpful Links

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)

March 23, 2017

Primary Completion (Actual)

November 3, 2025

Study Completion (Actual)

November 3, 2025

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360047-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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