HypertensionNCT02880631
BAROSTIM THERAPY™ In Resistant Hypertension
An observational study of Hypertension, run by CVRx, Inc. at 26 sites in 2 countries.
Trial summary
The purpose of this registry (NCT02880631) 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- BAROSTIM NEO™ System
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 13 Dec 2016to Jul 2027
- How long will I take part?
- 3 Years
- 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 Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension.
Who may be able to join
- Has signed an EC approved informed consent form
- Has been implanted with the BAROSTIM NEO system in the past 30 days
- 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
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
26 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 2 countries
Germany25 sites, 15 recruiting
- Active, not recruiting
Charité Benjamin Franklin
Berlin, 12203
- Active, not recruiting
Charité Campus Virchow
Berlin, 13353
- Recruiting
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321
Daniela Bettin, +49 333 869 4604, d.bettin@immanuel.de
Christian Butter
- Active, not recruiting
Cloppenburg Katholische Kliniken Münsterland
Cloppenburg, 49661
- Recruiting
Universitätsklinikum Köln Herzzentrum
Cologne, 50937
Tatjana Schewior, +49 221 478 88273, Tatjana.schewior@uk-koeln.de
Marcel Halbach
- Recruiting
Lippe Klinikum
Detmold, 32756
Angelika Göckeler, +49 5231 72 5727, Angelika.Goeckeler@klinikum-lippe.de
Dirk Haertel
- Recruiting
Herzzentrum Dresden
Dresden, 01307
Cornelia Fritz, +49 351 450 1332, cornelia.fritz@tu-dresden.de
Robert Höllriegel
- Active, not recruiting
Krankenhaus Erding
Erding, 85435
- Recruiting
Cardiovascular Center 'CVC' Frankfurt
Frankfurt, 60398
Sabine De Bruijn, +49 69 97347653, s.debruijn@cvcfrankfurt.de
Horst Sievert
- Recruiting
Universitätsklinikum Gießen und Marburg
Giessen, 35392
Gabriele Hellwig, +49 641 985 42632, gabriele.hellwig@med.uni-giessen.de
Jörn Schmitt
- Recruiting
Herzzentrum Göttingen
Göttingen, 37075
Christine Biegler, +49 551-39-10880, cbiegler@med.uni-goettingen.de
Marco Schroeter
- Recruiting
Asklepios Klinik Altona
Hamburg, 22763
Christine Neumann, +49401818818635, chris.neumann@asklepios.com
Jochen Müller-Ehmsen
- Active, not recruiting
St. Barbara Klinik Hamm
Hamm, 59073
- Recruiting
Kardiologie im Klinikum Ingolstadt
Ingolstadt, 85049
Kathrin Thiele, +49 841 880 2157, Kathrin.Thiele@klinikum-ingolstadt.de
Steffen Christow
- Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, 24105
Anika Struve, +49 431 500 22915, anika.struve@uksh.de
Hendrik Bonnemeier
- Active, not recruiting
Herzentrum Lahr
Lahr, 77933
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04109
Jenny Dietrich, +49 341 9712 408, jenny.dietrich@medizin.uni-leipzig.de
Janine Starke, +49 (341) 97 12 443f, janine.starke@medizin.uni-leipzig.de
- Active, not recruiting
Universitätsklinik Mainz
Mainz, 55131
- Active, not recruiting
Papenburg Marien Krankenhaus
Papenburg, 26871
- Recruiting
Universitätsklinikum Regensburg
Regensburg, 93053
Esther Keller, +49 941 944 7337, Esther.Kellner@ukr.de
Marcus Fischer
- Recruiting
Marienkrankenhaus Siegen
Siegen, 57072
Christoph Blanke, +49 2711 231 1215, c.blanke@marienkrankenhaus.com
Michael Buerke
- Active, not recruiting
Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH
Stadtlohn, 48970
- Recruiting
Klinikum Stuttgart
Stuttgart, 70174
Simone Bohn, +49 0711 278-35301, S.Bohn@klinikum-stuttgart.de
Vedat Schwenger
- Recruiting
Klinikum Tuttlingen
Tuttlingen, 78532
Ida Weber, +49 7461 97 1415, i.weber@klinikum-tut.de
Michael Kotzerke
- Active, not recruiting
Heinrich-Braun Klinikum
Zwickau, 08060
Netherlands1 site
- Active, not recruiting
Maastricht University Medical Center
Maastricht, 6229
About this study
Official title: BAROSTIM THERAPY™ In Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
The purpose of this registry (NCT02880631) 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.
Read the detailed description
Summary:
The CVRx BAROSTIM THERAPY in Resistant Hypertension 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. 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. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry.
Eligibility:
Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate.
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These 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
- Hypertension
- Being tested
- BAROSTIM NEO™ System
- Medical subject headings
- Hypertension
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.
Blood Pressure Changes
The results of an 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), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Measured: Pre-implant baseline to 3 years post-implant
Cardiovascular Medication Changes
Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Measured: Post-implant enrollment to 3 years post-implant
Number of Health Care Utilizations
Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Measured: 3 months post-implant to 3 years 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 (4)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 3 Years
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hannes Reuter, PhD, Study chair, Herzzentrum Uniklinik Köln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880631
- Sponsor's protocol ID
- 360051-001
- Status last verified
- Sep 2026
- First submitted
- 15 Aug 2016
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, Luft FC, Haller H, Menne J, Engeli S, Ceral J, Eckert S, Erglis A, Narkiewicz K, Philipp T, de Leeuw PW. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010 Oct 5;56(15):1254-8. doi: 10.1016/j.jacc.2010.03.089.
PubMed 20883933Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, de Leeuw PW, Sica DA. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol. 2011 Aug 9;58(7):765-73. doi: 10.1016/j.jacc.2011.06.008.
PubMed 21816315Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. 2012 Mar-Apr;6(2):152-8. doi: 10.1016/j.jash.2012.01.003. Epub 2012 Feb 15.
PubMed 22341199Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012 Jul-Aug;6(4):270-6. doi: 10.1016/j.jash.2012.04.004. Epub 2012 Jun 12.
PubMed 22694986
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 Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
- ClinicalTrials.gov ID
- NCT02880631
- Acronym / sponsor ID
- 360051-001
- Conditions
- Hypertension
- 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 (NCT02880631) 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.
Detailed description
Summary:
The CVRx BAROSTIM THERAPY in Resistant Hypertension 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. 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. After 12 months, data may be obtained in six month intervals for up to three years after implant, at which time each subject will be exited from the registry.
Eligibility:
Subjects must sign an Ethics Committee (EC) approved informed consent form for the registry to participate.
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension. These 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
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension.
Key inclusion criteria (4 listed)
- Has signed an EC approved informed consent form
- Has been implanted with the BAROSTIM NEO system in the past 30 days
- 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
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
Blood Pressure Changes
Time frame: Pre-implant baseline to 3 years post-implant
The results of an 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), at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Cardiovascular Medication Changes
Time frame: Post-implant enrollment to 3 years post-implant
Information on currently-utilized doses of cardiovascular medications will be collected at pre-implant baseline, 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
Number of Health Care Utilizations
Time frame: 3 months post-implant to 3 years post-implant
Health care utilization information (e.g. heart failure hospitalizations) is collected at 3- and 6- and 12-months post-implant, and then every 6 months up to 3 years from implant.
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 20883933Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, Luft FC, Haller H, Menne J, Engeli S, Ceral J, Eckert S, Erglis A, Narkiewicz K, Philipp T, de Leeuw PW. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010 Oct 5;56(15):1254-8. doi: 10.1016/j.jacc.2010.03.089.
- Background: PubMed 21816315Bisognano JD, Bakris G, Nadim MK, Sanchez L, Kroon AA, Schafer J, de Leeuw PW, Sica DA. Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled rheos pivotal trial. J Am Coll Cardiol. 2011 Aug 9;58(7):765-73. doi: 10.1016/j.jacc.2011.06.008.
- Background: PubMed 22341199Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. J Am Soc Hypertens. 2012 Mar-Apr;6(2):152-8. doi: 10.1016/j.jash.2012.01.003. Epub 2012 Feb 15.
- Background: PubMed 22694986Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012 Jul-Aug;6(4):270-6. doi: 10.1016/j.jash.2012.04.004. Epub 2012 Jun 12.
- BAROSTIM THERAPY websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Hannes Reuter, PhD study chair
Herzzentrum Uniklinik Köln
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by CVRx, Inc. at 26 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 4 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 26 sites in Germany, Netherlands. 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?
Blood Pressure Changes (time frame: Pre-implant baseline to 3 years post-implant). The study lists 3 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 NCT02880631, which also lists 4 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.