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Neck implant aims to tame stubborn high blood pressure

NCT ID NCT01679132

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 studying the long-term safety and effectiveness of the Barostim Neo System in people with uncontrolled high blood pressure who already received the implant. Participants continue their usual blood pressure medications while the device stimulates nerves in the neck that help regulate blood pressure. The study tracks adverse events over time to see how well the device performs alongside medical management.

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 in the neck to lower blood pressure
What this could lead to
If it works, this could offer a device-based option for people whose high blood pressure stays uncontrolled despite multiple medications.
What could go wrong
This is a small, long-term follow-up study of people already implanted, so it cannot prove the device lowers blood pressure on its own. Implant surgery carries risks like infection or nerve injury, and the device may not help everyone.

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

10 people

The number who actually took part.

Started

Apr 2013

Finished

Jul 2025

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 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. 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.

Uncontrolled hypertension

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Heart Rhythm Research Center

    Phoenix, Arizona, 85006, United States

  • Aspirus Wausau Hospital

    Wausau, Wisconsin, 54401, United States

  • Cardiac and Vascular Research Center of Northern Michigan

    Petosky, Michigan, 49770, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Florida Hospital

    Orlando, Florida, 32803, United States

  • George Washington University

    Washington D.C., District of Columbia, 20037, United States

  • Michigan CardioVascular Institute

    Saginaw, Michigan, 48601, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

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