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Implanted device aims to ease heart failure symptoms

NCT ID NCT02876042

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether the Barostim NEO device, which stimulates a nerve near the carotid artery to lower blood pressure, can help people with heart failure and preserved ejection fraction. The registry follows 11 people who already received the device for resistant hypertension and also have this type of heart failure. The team tracks changes in blood pressure and heart function over six months to see if the device offers any benefit for heart failure.

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 device, an implanted device that stimulates the carotid baroreceptor to lower blood pressure
What this could lead to
If the device helps, it could offer a new way to manage heart failure with preserved ejection fraction, a condition with few effective treatments.
What could go wrong
This is a small registry of 11 people, so any findings may not apply broadly. The device is already approved for resistant hypertension, but its effect on heart failure symptoms remains uncertain.

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

11 people

The number who actually took part.

Started

Mar 2017

Finished

Nov 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.

Who is studied

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria.

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: * Sign an Ethics Committee (EC) approved informed consent form for the registry. * Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment. * BAROSTIM THERAPY not yet chronically activated. * Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant. * On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment. * Objective evidence of heart failure according to the following criteria: * Hospitalization for heart failure within 12 months prior to enrollment OR * Echocardiographic evidence of diastolic dysfunction (LA Volume Index \>34 ml/m2 OR E/e \>13) within 30 days prior to enrollment OR * NTproBNP \> 220 pg/mL or BNP \> 80 pg/mL (in atrial fibrillation, NTproBNP \> 600 pg/mL or BNP \> 200 pg/mL) within 30 days prior to enrollment Exclusion Criteria: * Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction. * Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • Asklepios Klinik Altona

    Hamburg, 22763, Germany

  • Berlin Charité & Deutschen Herzzentrum Berlin

    Berlin, 12203, Germany

  • Herzzentrum Göttingen

    Göttingen, 37075, Germany

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau, 16321, Germany

  • Kardiologie im Klinikum Ingolstadt

    Ingolstadt, 85049, Germany

  • Lippe Klinikum

    Detmold, 32756, Germany

  • Marienkrankenhaus Siegen

    Siegen, 57072, Germany

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Uniklinik Frankfurt

    Frankfurt, 60590, Germany

  • Uniklinik Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Gießen und Marburg

    Giessen, 35392, Germany

  • Universitätsklinikum Köln Herzzentrum

    Cologne, 50937, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

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