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Implanted neck device aims to tame stubborn high blood pressure

NCT ID NCT01471834

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are following people with high blood pressure who already received the Barostim Neo, a small implanted device that stimulates the body's own blood pressure sensors. The study tracks long-term safety and how well the device keeps blood pressure under control. Participants continue with standard blood pressure medications alongside the device. The goal is to see whether the benefits last and what side effects appear over time.

What this could mean

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

Active substance
Barostim Neo, an implanted device that stimulates the body's pressure sensors to lower blood pressure
What this could lead to
If the device proves safe and effective over years, it could offer a lasting option for people whose high blood pressure resists standard drugs.
What could go wrong
This is a small, non-randomized follow-up study, so it cannot prove the device works better than other treatments. Implanted devices carry risks of infection, surgical complications, and device failure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Start date

Jun 2011

Expected to finish

Dec 2026

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.

Ages

21 to 80 years

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: * Actively participating in the Neo Non-Randomized Hypertension Study. * Have signed a revised approved informed consent form for continued participation in this study. Exclusion Criteria: * Treating physician decision that the subject should not continue with therapy.

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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.

High blood pressure

Contacts and locations

Locations

  • Goettingen-Georg August University

    Göttingen, 37075, Germany

  • Klinkum St. George Leipzig

    Leipzig, 04129, Germany

  • London-Lawson Health Research Institute

    London, Ontario, N6G 2V2, Canada

  • Maastricht University

    Maastricht, HX6229, Netherlands

  • Midizinische Hochschule Hannover

    Hanover, 30625, Germany

  • University Hospital Cologne

    Cologn, 50924, Germany

  • University Hospital Duesseldorf

    Düsseldorf, 40225, Germany

  • University of Alberta - Edmonton

    Edmonton, Alberta, T2P 1C4, Canada

  • University of Calgary

    Calgary, Alberta, T2N 2T9, Canada

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