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Nerve-stimulating implant tested for easing heart failure symptoms

NCT ID NCT02880618

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tracking 500 people with heart failure and reduced ejection fraction who received the Barostim Neo device, which stimulates nerves near the carotid artery to calm the body's stress response. The registry follows participants for six months to see whether the device improves heart failure classification, walking distance, heart structure, blood biomarkers, and hospitalizations. This is an observational study, so it cannot prove the device works, but it collects real-world data on how people fare after implantation.

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 System, an implanted device that stimulates the carotid artery baroreceptors to regulate the nervous system
What this could lead to
If the device helps, it could offer a new option for people with heart failure whose symptoms persist despite standard medications.
What could go wrong
This is a registry, not a randomized trial, so it cannot prove the device causes any improvement. Implanting a device carries risks of surgery and device-related complications.
Why investors are watching

CVRx sells the BAROSTIM NEO system, a device already approved in Europe for heart failure with reduced ejection fraction. This 500-person registry tracks how the therapy performs in routine commercial use, so the results shape how doctors and buyers view the device. For a micro-cap company with few products, that evidence matters to its core business.

If it works: Positive registry results could support wider adoption of BAROSTIM among heart failure doctors and strengthen the company's position with regulators and payers.

If it fails: Weak or delayed results could slow adoption and leave the company with limited evidence for its main product. Registries of this kind often produce mixed or inconclusive findings.

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 Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure.

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: * Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy * Subject has been implanted with the BAROSTIM NEO System in the past 30 days * Subject has signed an Ethics Committee approved informed consent form 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.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure

How to take part

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

  1. The places running it

    5 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

  • Albertinen-Krankenhaus

    ACTIVE_NOT_RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22457, Germany

  • Asklepios Klinik Altona

    ACTIVE_NOT_RECRUITING

    Hamburg, 22763, Germany

  • Berlin Charité & Deutschen Herzzentrum Berlin

    ACTIVE_NOT_RECRUITING

    Berlin, 12203, Germany

  • Charité Campus Virchow Klinikum

    ACTIVE_NOT_RECRUITING

    Berlin, 13353, Germany

  • Clemenshospital Münster

    ACTIVE_NOT_RECRUITING

    Münster, 48153, Germany

  • Dresden Friedrichstadt

    ACTIVE_NOT_RECRUITING

    Dresden, 01067, Germany

  • Fondazione di Ricerca e Cura "Giovanni Paolo II"

    ACTIVE_NOT_RECRUITING

    Campobasso, 86100, Italy

  • Herzentrum Lahr

    ACTIVE_NOT_RECRUITING

    Lahr, 77933, Germany

  • Herzzentrum Bad Oyenhausen

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Herzzentrum Dresden - Interventionelle Kardiologie

    ACTIVE_NOT_RECRUITING

    Dresden, 01307, Germany

  • Herzzentrum Dresden, Elektrophysiologie

    ACTIVE_NOT_RECRUITING

    Dresden, 01307, Germany

  • Herzzentrum Göttingen

    TERMINATED

    Göttingen, 37075, Germany

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    ACTIVE_NOT_RECRUITING

    Bernau, 16321, Germany

  • Kardiologie im Klinikum Ingolstadt

    ACTIVE_NOT_RECRUITING

    Ingolstadt, 85049, Germany

  • Klinikum Tuttlingen

    RECRUITING

    Tuttlingen, 78532, Germany

  • Krankenhaus & MVZ Maria-Hilf Stadtlohn GmbH

    ACTIVE_NOT_RECRUITING

    Stadtlohn, 48970, Germany

  • Leipzig St. Georg

    RECRUITING

    Leipzig, 04129, Germany

  • Lippe Klinikum

    ACTIVE_NOT_RECRUITING

    Detmold, 32756, Germany

  • Marienkrankenhaus Siegen

    ACTIVE_NOT_RECRUITING

    Siegen, 57072, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Medizinisches Versorgungszentrum am Küchwald GmbH

    ACTIVE_NOT_RECRUITING

    Chemnitz, 09113, Germany

  • St. Barbara Klinik Hamm

    ACTIVE_NOT_RECRUITING

    Hamm, 59073, Germany

  • St. Vincenz-Krankenhaus

    ACTIVE_NOT_RECRUITING

    Paderborn, 33098, Germany

  • Uniklinik Frankfurt

    ACTIVE_NOT_RECRUITING

    Frankfurt, 60590, Germany

  • Universitätsklinik Mainz

    ACTIVE_NOT_RECRUITING

    Mainz, 55131, Germany

  • Universitätsklinikum Gießen und Marburg

    RECRUITING

    Giessen, 35392, Germany

  • Universitätsklinikum Köln Herzzentrum

    ACTIVE_NOT_RECRUITING

    Cologne, 50937, Germany

  • Universitätsklinikum Leipzig

    ACTIVE_NOT_RECRUITING

    Leipzig, 04109, Germany

  • Universitätsklinikum Regensburg

    ACTIVE_NOT_RECRUITING

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    ACTIVE_NOT_RECRUITING

    Kiel, 24105, Germany

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