Uncontrolled HypertensionNCT01679132
BAROSTIM NEO Hypertension Pivotal Trial
A study testing BAROSTIM NEO System and Medical Management in people with Uncontrolled Hypertension, run by CVRx, Inc. at 11 sites in United States.
Trial summary
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Uncontrolled Hypertension
- 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
- 10 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Apr 2013to 23 Jul 2025
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
- 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Cardiovascular Institute of the South
Houma, Louisiana, 70360
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
University of Southern California
Los Angeles, California, 90033
Florida Hospital
Orlando, Florida, 32803
Cardiac and Vascular Research Center of Northern Michigan
Petosky, Michigan, 49770
Arizona Heart Rhythm Research Center
Phoenix, Arizona, 85006
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Michigan CardioVascular Institute
Saginaw, Michigan, 48601
Tampa General Hospital
Tampa, Florida, 33606
George Washington University
Washington D.C., District of Columbia, 20037
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401
About this study
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
Read the detailed description
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
- Office Cuff Blood Pressure
- Physical Assessment
- Subject Medications
- Serious adverse events
- Conditions
- Uncontrolled Hypertension
- Being tested
- BAROSTIM NEO System and Medical Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAROSTIM NEO System and Medical ManagementDevice
Also called Neo System
Experimental: Device and Medical Management
Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.
| Study group | Role | What they receive |
|---|---|---|
| BAROSTIM NEO System | Experimental | Subjects implanted with the BAROSTIM NEO System. Receives: Device: BAROSTIM NEO System and Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
Measured: For the duration of the study, up to ten years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study start12 Apr 2013
- Primary completionJul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CVRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Bakris, MD, Study chair, The University of Chicago MedicineJohn Bisognano, MD, Study chair, University of RochesterFred Weaver, MD, Study chair, Keck School of Medicine of the University of Southern CaliforniaWilliam Abraham, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679132
- Sponsor's protocol ID
- 360039
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2012
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 NEO Hypertension Pivotal Trial
- ClinicalTrials.gov ID
- NCT01679132
- Acronym / sponsor ID
- 360039
- Conditions
- Uncontrolled Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CVRx, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2013 (actual)
- Primary completion
- Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 5 Sep 2012 (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 clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
Detailed description
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.
All subjects are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during visits are:
- Office Cuff Blood Pressure
- Physical Assessment
- 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 |
|---|---|---|
| BAROSTIM NEO System | Experimental | Device: BAROSTIM NEO System and Medical ManagementSubjects implanted with the BAROSTIM NEO System. |
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 Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
- 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 System and Medical ManagementAlso: Neo SystemExperimental: Device and Medical Management Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators. | Device | BAROSTIM NEO System |
Primary outcome
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Time frame: For the duration of the study, up to ten years.
Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
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.
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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.
George Bakris, MD study chair
The University of Chicago Medicine
John Bisognano, MD study chair
University of Rochester
Fred Weaver, MD study chair
Keck School of Medicine of the University of Southern California
11 sites in 1 country: 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 Uncontrolled Hypertension, run by CVRx, Inc. at 11 sites in United States.
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: 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 11 sites in United States. 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?
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. (time frame: For the duration of the study, up to ten years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.