Heart FailureHFpEFNCT02876042
BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, run by CVRx, Inc. at 13 sites in Germany.
Trial summary
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). 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
- 11 participants
- Where
- 13 sitesGermany
- Study dates
- 23 Mar 2017to 3 Nov 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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.
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Berlin Charité & Deutschen Herzzentrum Berlin
Berlin, 12203
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321
Universitätsklinikum Köln Herzzentrum
Cologne, 50937
Lippe Klinikum
Detmold, 32756
Uniklinik Frankfurt
Frankfurt, 60590
Universitätsklinikum Gießen und Marburg
Giessen, 35392
Herzzentrum Göttingen
Göttingen, 37075
Asklepios Klinik Altona
Hamburg, 22763
Medizinische Hochschule Hannover
Hanover, 30625
Uniklinik Heidelberg
Heidelberg, 69120
Kardiologie im Klinikum Ingolstadt
Ingolstadt, 85049
Universitätsklinikum Regensburg
Regensburg, 93053
Marienkrankenhaus Siegen
Siegen, 57072
About this study
Official title: 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).
Read the 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
- 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
Implantation of the BAROSTIM NEO™ System
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Office Cuff Systolic Blood Pressure
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.
Measured: Pre-implant baseline to 6 months post-implant
Secondary outcomes (6)
Change in New York Heart Association Functional Classification
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.
Measured: Pre-implant baseline to 6 months post-implant
Changes in Left Ventricular Mass Index
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.
Measured: Pre-implant baseline to 6 months post-implant
Changes in LA volume index
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.
Measured: Pre-implant baseline to 6 months post-implant
Changes in E/E' ratio
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.
Measured: Pre-implant baseline to 6 months post-implant
Changes in NT-proBNP
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.
Measured: Pre-implant baseline, 6 months post-implant
Evaluate health care utilization over follow-up, such as heart failure hospitalizations
Health care utilization information is collected throughout follow-up.
Measured: Pre-implant baseline to 6 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 posted23 Aug 2016 (estimated)
- Study start23 Mar 2017
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 11 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Burkert Pieske, PhD, Study chair, Universitätmedizin Berlin - Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876042
- Sponsor's protocol ID
- 360047-001
- Acronym
- HFpEF
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2016
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.
PubMed 21300307
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 Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
- ClinicalTrials.gov ID
- NCT02876042
- Acronym / sponsor ID
- HFpEF / 360047-001
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 23 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 (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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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™ SystemImplantation of the BAROSTIM NEO™ System | Device | – |
Primary outcome
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.
6 secondary outcomes
Change in New York Heart Association Functional Classification
Time frame: Pre-implant baseline to 6 months post-implant
Changes in Left Ventricular Mass Index
Time frame: Pre-implant baseline to 6 months post-implant
Changes in LA volume index
Time frame: Pre-implant baseline to 6 months post-implant
Changes in E/E' ratio
Time frame: Pre-implant baseline to 6 months post-implant
Changes in NT-proBNP
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 21300307Georgakopoulos D, Little WC, Abraham WT, Weaver FA, Zile MR. Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. J Card Fail. 2011 Feb;17(2):167-78. doi: 10.1016/j.cardfail.2010.09.004. Epub 2010 Oct 29.
- BAROSTIM THERAPY websiteLink 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. This study is not recruiting at the moment.
Burkert Pieske, PhD study chair
Universitätmedizin Berlin - Charité
13 sites in 1 country: 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 13 sites in Germany.
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 9 inclusion and 2 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: finished, 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 13 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Office Cuff Systolic Blood Pressure (time frame: Pre-implant baseline to 6 months post-implant). 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 NCT02876042, which also lists 1 linked publication.
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.