High Blood PressureNCT01471834
Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension
A study testing BAROSTIM NEO System and Medical Management in people with High Blood Pressure, run by CVRx, Inc. at 9 sites in 3 countries.
Trial summary
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- BAROSTIM NEO System and Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Jun 2011to Dec 2026
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Actively participating in the Neo Non-Randomized Hypertension Study.
- Have signed a revised approved informed consent form for continued participation in this study.
Who cannot join
- Treating physician decision that the subject should not continue with therapy.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany5 sites
University Hospital Cologne
Cologn, 50924
University Hospital Duesseldorf
Düsseldorf, 40225
Goettingen-Georg August University
Göttingen, 37075
Midizinische Hochschule Hannover
Hanover, 30625
Klinkum St. George Leipzig
Leipzig, 04129
Canada3 sites
University of Calgary
Calgary, Alberta, T2N 2T9
University of Alberta - Edmonton
Edmonton, Alberta, T2P 1C4
London-Lawson Health Research Institute
London, Ontario, N6G 2V2
About this study
Official title: Neo Non-Randomized Hypertension Study
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.
Read the detailed description
The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.
Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- Physical Assessment
- Office Cuff Blood Pressure
- Subject Medications
- Serious adverse events
- Conditions
- High Blood Pressure
- Being tested
- BAROSTIM NEO System, Medical Management
- 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
Also called XR-1 System, Neo System
Medical ManagementDrug
| Study group | Role | What they receive |
|---|---|---|
| Device and Medical Management | Experimental | Participants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. Receives: Device: BAROSTIM NEO System; Drug: Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with CVRx's BAROSTIM NEO System.
Measured: For the duration of the study, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionDec 2026 (estimated)
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 High Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hermann Haller, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471834
- Sponsor's protocol ID
- 360016
- Status last verified
- Sep 2026
- First submitted
- 9 Nov 2011
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.
PubMed 28065708
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo Non-Randomized Hypertension Study
- ClinicalTrials.gov ID
- NCT01471834
- Acronym / sponsor ID
- 360016
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Nov 2011 (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.
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.
Detailed description
The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.
Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
- Physical Assessment
- Office Cuff Blood Pressure
- Subject Medications
- Serious adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device and Medical Management | Experimental | Device: BAROSTIM NEO System, Drug: Medical ManagementParticipants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Actively participating in the Neo Non-Randomized Hypertension Study.
- Have signed a revised approved informed consent form for continued participation in this study.
Key exclusion criteria (1 listed)
- Treating physician decision that the subject should not continue with therapy.
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 SystemAlso: XR-1 System, Neo System | Device | Device and Medical Management |
| Medical Management | Drug | Device and Medical Management |
Primary outcome
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
Time frame: For the duration of the study, up to 10 years.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with CVRx's BAROSTIM NEO System.
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 10 Sep 2026.
- Derived from this study: PubMed 28065708Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.
Related trials for High Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Hermann Haller, MD principal investigator
Hannover Medical School
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAROSTIM NEO System and Medical Management in people with High Blood Pressure, run by CVRx, Inc. at 9 sites in 3 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 10 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 9 sites in Germany, Canada, 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?
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?
To access long-term adverse events in participants implanted with the BAROSTIM NEO System. (time frame: For the duration of the study, up to 10 years.). 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 NCT01471834, 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 10 Sep 2026.