Heart FailureHFrEFNCT02880618
BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
An observational study of Heart Failure, run by CVRx, Inc. at 30 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Barostim Neo™ System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 13 Dec 2016to Jul 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
30 sites in 2 countries
Germany29 sites, 5 recruiting
- Recruiting
Herzzentrum Bad Oyenhausen
Bad Oeynhausen, 32545
Birgit Wellmann, +49 5721 973327, Bwellmann@hdz-nrw.de
Klaus-Jürgen Gutleben
- Active, not recruiting
Berlin Charité & Deutschen Herzzentrum Berlin
Berlin, 12203
- Active, not recruiting
Charité Campus Virchow Klinikum
Berlin, 13353
- Active, not recruiting
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321
- Active, not recruiting
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, 09113
- Active, not recruiting
Universitätsklinikum Köln Herzzentrum
Cologne, 50937
- Active, not recruiting
Lippe Klinikum
Detmold, 32756
- Active, not recruiting
Dresden Friedrichstadt
Dresden, 01067
- Active, not recruiting
Herzzentrum Dresden - Interventionelle Kardiologie
Dresden, 01307
- Active, not recruiting
Herzzentrum Dresden, Elektrophysiologie
Dresden, 01307
- Active, not recruiting
Uniklinik Frankfurt
Frankfurt, 60590
- Recruiting
Universitätsklinikum Gießen und Marburg
Giessen, 35392
Gabriele Hellwig, +49 641 985 42632, gabriele.hellwig@med.uni-giessen.de
Jörn Schmitt
- Terminated
Herzzentrum Göttingen
Göttingen, 37075
- Active, not recruiting
Albertinen-Krankenhaus
Hamburg, Free and Hanseatic City of Hamburg, 22457
- Active, not recruiting
Asklepios Klinik Altona
Hamburg, 22763
- Active, not recruiting
St. Barbara Klinik Hamm
Hamm, 59073
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Antje Jürgens, +49 511 532 6054, juergens.antje@mh-hannover.de
Christian Veltmann
- Active, not recruiting
Kardiologie im Klinikum Ingolstadt
Ingolstadt, 85049
- Active, not recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
- Active, not recruiting
Herzentrum Lahr
Lahr, 77933
- Active, not recruiting
Universitätsklinikum Leipzig
Leipzig, 04109
- Recruiting
Leipzig St. Georg
Leipzig, 04129
Susanne Reichelt, +49 341 909-4561, susanne.reichelt@sanktgeorg.de
Norbert Klein
- Active, not recruiting
Universitätsklinik Mainz
Mainz, 55131
- Active, not recruiting
Clemenshospital Münster
Münster, 48153
- Active, not recruiting
St. Vincenz-Krankenhaus
Paderborn, 33098
- Active, not recruiting
Universitätsklinikum Regensburg
Regensburg, 93053
- Active, not recruiting
Marienkrankenhaus Siegen
Siegen, 57072
- Active, not recruiting
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, 48970
- Recruiting
Klinikum Tuttlingen
Tuttlingen, 78532
Ida Weber, +49 7461 97 1415, i.weber@klinikum-tut.de
Michael Kotzerke
Italy1 site
- Active, not recruiting
Fondazione di Ricerca e Cura "Giovanni Paolo II"
Campobasso, 86100
About this study
Official title: 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).
Read the 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
- Conditions
- Heart Failure
- Being tested
- Barostim Neo™ System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barostim Neo™ SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in New York Heart Association Functional Classification at 6 months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
Measured: Baseline, 6 months post-implant
Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
Measured: Baseline, 6 months post-implant
Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
Measured: 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)
To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
Measured: Baseline, 6 months post-implant
Number of Hospitalizations over Follow-Up
To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
Measured: 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start13 Dec 2016
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jochen Müller-Ehmsen, PhD, Study chair, Asklepios Klinik Altona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880618
- Sponsor's protocol ID
- 360049-001
- Acronym
- HFrEF
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2016
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
PubMed 25982108Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
PubMed 26011593Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28.
PubMed 25067799Gronda E, Seravalle G, Trevano FQ, Costantino G, Casini A, Alsheraei A, Lovett EG, Vanoli E, Mancia G, Grassi G. Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. J Hypertens. 2015 Aug;33(8):1704-8. doi: 10.1097/HJH.0000000000000603.
PubMed 26132760Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2.
PubMed 28043438
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
- ClinicalTrials.gov ID
- NCT02880618
- Acronym / sponsor ID
- HFrEF / 360049-001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barostim Neo™ System | Device | – |
Primary outcome
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.
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.
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.
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.
Number of Hospitalizations over Follow-Up
Time frame: 12 months post-implant
To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 25982108Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
- Background: PubMed 26011593Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
- Background: PubMed 25067799Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28.
- Background: PubMed 26132760Gronda E, Seravalle G, Trevano FQ, Costantino G, Casini A, Alsheraei A, Lovett EG, Vanoli E, Mancia G, Grassi G. Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. J Hypertens. 2015 Aug;33(8):1704-8. doi: 10.1097/HJH.0000000000000603.
- Background: PubMed 28043438Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2.
- BAROSTIM THERAPYLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jochen Müller-Ehmsen, PhD study chair
Asklepios Klinik Altona
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by CVRx, Inc. at 30 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Baumann (763-416-2331, nbaumann@cvrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in New York Heart Association Functional Classification at 6 months Post-Implant (time frame: Baseline, 6 months post-implant). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880618, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.