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A neck implant aims to quiet Hard-to-Treat high blood pressure

NCT ID NCT02880631

Disease control Sponsor: CVRx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are following 500 people with resistant hypertension who have received the Barostim Neo device, an implant that stimulates blood pressure sensors in the neck. The registry tracks blood pressure readings, changes in blood pressure medications, and health care visits over up to three years. The goal is to see how the device performs in everyday medical practice, not just in controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an implanted device that stimulates the body's blood pressure sensors in the neck (baroreflex activation therapy)
What this could lead to
If the approach works, it could offer people with resistant hypertension a device-based way to lower blood pressure when drugs are not enough.
What could go wrong
This is a registry that observes people after they receive a commercially available device, so it cannot prove the device causes any changes. Implanting a device carries surgical risks, and results may not apply to everyone.
Why investors are watching

CVRx sells the BAROSTIM NEO system, a device already approved in Europe for resistant hypertension, and this 500-patient registry tracks how the therapy performs once doctors use it in routine commercial practice. For a micro-cap company, real-world results from that many patients can shape whether doctors and payers keep adopting the device.

If it works: If the registry shows the therapy controls blood pressure well in everyday use, CVRx may point to that evidence when it talks to physicians and payers, which may support wider use of the device.

If it fails: If the registry shows weak blood pressure control or frequent problems, that evidence may slow adoption and hurt the company's commercial prospects. Registries like this can also take years to complete or report, and delays are common.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2016

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

hypertensive disorder resistant hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Cardiovascular Center 'CVC' Frankfurt

    RECRUITING

    Frankfurt, 60398, Germany

  • Charité Benjamin Franklin

    ACTIVE_NOT_RECRUITING

    Berlin, 12203, Germany

  • Charité Campus Virchow

    ACTIVE_NOT_RECRUITING

    Berlin, 13353, Germany

  • Cloppenburg Katholische Kliniken Münsterland

    ACTIVE_NOT_RECRUITING

    Cloppenburg, 49661, Germany

  • Heinrich-Braun Klinikum

    ACTIVE_NOT_RECRUITING

    Zwickau, 08060, Germany

  • Herzentrum Lahr

    ACTIVE_NOT_RECRUITING

    Lahr, 77933, Germany

  • Herzzentrum Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Herzzentrum Göttingen

    RECRUITING

    Göttingen, 37075, Germany

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    RECRUITING

    Bernau, 16321, Germany

  • Kardiologie im Klinikum Ingolstadt

    RECRUITING

    Ingolstadt, 85049, Germany

  • Klinikum Stuttgart

    RECRUITING

    Stuttgart, 70174, Germany

  • Klinikum Tuttlingen

    RECRUITING

    Tuttlingen, 78532, Germany

  • Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH

    ACTIVE_NOT_RECRUITING

    Stadtlohn, 48970, Germany

  • Krankenhaus Erding

    ACTIVE_NOT_RECRUITING

    Erding, 85435, Germany

  • Lippe Klinikum

    RECRUITING

    Detmold, 32756, Germany

  • Maastricht University Medical Center

    ACTIVE_NOT_RECRUITING

    Maastricht, 6229, Netherlands

  • Marienkrankenhaus Siegen

    RECRUITING

    Siegen, 57072, Germany

  • Papenburg Marien Krankenhaus

    ACTIVE_NOT_RECRUITING

    Papenburg, 26871, Germany

  • St. Barbara Klinik Hamm

    ACTIVE_NOT_RECRUITING

    Hamm, 59073, Germany

  • Universitätsklinik Mainz

    ACTIVE_NOT_RECRUITING

    Mainz, 55131, Germany

  • Universitätsklinikum Gießen und Marburg

    RECRUITING

    Giessen, 35392, Germany

  • Universitätsklinikum Köln Herzzentrum

    RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, 04109, Germany

  • Universitätsklinikum Regensburg

    RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

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