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Could a Pacemaker-Like device ease heart failure?

NCT ID NCT02627196

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tested a device called Barostim neo that stimulates nerves to help control blood pressure in people with advanced heart failure. Over 1,000 participants received either the device or standard medical care. The goal was to see if the device could reduce heart-related deaths and hospital stays, and improve quality of life.

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 (a device that activates baroreflex to regulate blood pressure)
What this could lead to
If successful, this device could offer a new way to manage advanced heart failure, reducing hospital stays and improving daily function.
What could go wrong
This is a completed trial, but results are not yet widely available. The device requires surgical implantation, which carries risks like infection or nerve injury. It may not work for 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

1,090 people

The number who actually took part.

Started

Apr 2016

Finished

Oct 2023

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 years and older

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: 1. Age 21 years or above. 2. Currently NYHA Class II or III heart failure. For NYHA Class II, must have been NYHA Class III at any point in time within 3 calendar months prior to enrollment or at time of screening (enrollment is defined as the date the subject provided written consent). 3. Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization. 4. Heart failure accompanied by either: * Core lab NT-proBNP ≥ 400 AND \<1600 pg/ml within 45 days prior to randomization OR * Core lab NT-proBNP \< 400 pg/ml within 45 days prior to randomization AND a heart failure hospitalization in the past 12 months. Note: Heart failure hospitalization may include an overnight hospital or hospital-based observation unit stay with a primary diagnosis of heart failure or an emergency room visit with a primary diagnosis of heart failure. Note: Screening/Baseline core lab NT-proBNP must be collected in an outpatient setting at a time when the subject is thought to be clinically stable. 5. On optimal, stable, Guideline Directed Medical Therapy (GDMT) per country specific guidelines for the treatment of heart-failure throughout screening/baseline evaluation and for at least 4 weeks prior to obtaining any post-consent screening parameters: * No more than a 100% increase or a 50% decrease of the dosage of any one medication other than a diuretic. * Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above. * Unrestricted changes in diuretics are allowed as long as the subject remains on a diuretic. 6. Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to randomization. 7. The artery planned for the BAROSTIM implant must meet both of the following criteria: * At least one carotid bifurcation as identification by a bilateral carotid duplex ultrasound within 6 months prior to randomization that is: 1. Below the level of the mandible AND 2. No ulcerative carotid arterial plaques AND 3. No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal carotid AND 4. No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the distal common carotid * No prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region. 8. If female and of childbearing potential, must use a medically accepted method of birth control (e.g., barrier method with spermicide, oral contraceptive, or abstinence) and agree to continue use of this method for the duration of the trial. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization. 9. Received a standard cardiac work up and is an appropriate candidate for the study and the surgical procedure as determined by a trial cardiologist and a trial surgeon. 10. Subjects implanted with a cardiac rhythm management device that does not utilize an intracardiac lead, or implanted with a neurostimulation device, must be approved by the CVRx Clinical department. 11. Signed a CVRx-approved informed consent form for participation in this trial. Exclusion Criteria: If any of the following criteria are met, subjects are not eligible for this trial. 1. Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT. 2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to AHA/ACC/ESC guidelines for the treatment of congestive heart failure. , 3. Known or suspected baroreflex failure or autonomic neuropathy. 4. AHA/ACC Stage D heart failure within 45 days prior to randomization. 5. Body mass index \> 40. 6. Serum estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m2 within 45 days prior to randomization. 7. Recurring resting heart rate of either \< 60 bpm or \> 100 bpm via clinic measurements within 45 days prior to randomization. (Note: Heart rate \<60 bpm is not applicable to subjects with an implanted device capable of pacing.) 8. Recurring symptomatic hypotension within 45 days prior to randomization. 9. Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular arrhythmias. 10. Subjects with any surgery that has occurred, or is planned to occur, within 45 days of the BAROSTIM NEO implant procedure. This includes pacemaker or ICD implants or battery replacements. 11. Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior to randomization. 12. Any of the following within 3 months of randomization: * Myocardial infarction * Unstable angina * Percutaneous coronary intervention (e.g. CABG or PTCA) * Cerebral vascular accident or transient ischemic attack * Sudden cardiac death 13. Solid organ or hematologic transplant, or currently being actively evaluated for an organ transplant. 14. Has received or is receiving LVAD therapy. 15. Has received or is receiving chronic dialysis. 16. Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction. 17. Primary pulmonary hypertension. 18. Infiltrative cardiomyopathy (e.g. cardiac amyloidosis). 19. Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use). 20. Active malignancy. 21. Current or planned treatment with intravenous positive inotrope therapy. 22. Life expectancy less than one year. 23. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. 24. Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements (e.g. recent drug abuse). 25. Enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical trial unless approved by the CVRx Clinical department. 26. Subjects with known allergies to silicone and titanium.

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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

Contacts and locations

Locations

  • Advanced Cardiovascular Specialists

    Mountain View, California, 94040, United States

  • AdventHealth Orlando

    Orlando, Florida, 32803, United States

  • Adventist Heart Institute

    St. Helena, California, 94574, United States

  • Advocate Medical Group

    Naperville, Illinois, 60540, United States

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016, United States

  • Ascension St. Mary's Research Institute

    Saginaw, Michigan, 48602, United States

  • Atlantic Clinical Research Center - Cardiology

    Atlantis, Florida, 33462, United States

  • Avanza Medical Research Center

    Pensacola, Florida, 32503, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Belfast Health & Social Care Trust

    Belfast, Northern Ireland, BT9 7AB, United Kingdom

  • Bonometti, Inc

    Santa Barbara, California, 93101, United States

  • CHI Franciscan Health Research Center

    Tacoma, Washington, 98405, United States

  • Cardiovascular Consultants, Ltd.

    Phoenix, Arizona, 85032, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231, United States

  • Central Cardiology Medical Center

    Bakersfield, California, 93308, United States

  • Chan Heart Rhythm Institute

    Mesa, Arizona, 85206, United States

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910, United States

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756, United States

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211, United States

  • Cone Health

    Greensboro, North Carolina, 27401, United States

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015, United States

  • Desert Heart Regional Medical Center

    Palm Springs, California, 92262, United States

  • Detroit Medical Center Cardiovascular Institute

    Detroit, Michigan, 48201, United States

  • Dignity Health

    Sacramento, California, 95819, United States

  • Drexel University

    Philadelphia, Pennsylvania, 19102, United States

  • Glendale Adventist Medical Center

    Glendale, California, 91204, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Healthcare Partners Clinical Research

    Las Vegas, Nevada, 89169, United States

  • Heart and Rhythm Solutions, PLLC

    Chandler, Arizona, 85286, United States

  • Herndon Surgery Center

    Fresno, California, 93720, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • Huntington Hospital

    Pasadena, California, 91105, United States

  • Intermountain Heart Institute

    Murray, Utah, 84107, United States

  • John Muir Health Clinical Research Center

    Concord, California, 94520, United States

  • Liverpool Heart and Chest Hospital

    Liverpool, Merseyside, L14 3PE, United Kingdom

  • Los Alamitos Cardiovascular

    Los Alamitos, California, 90720, United States

  • McLeod Cardiology Associates

    Florence, South Carolina, 29506, United States

  • Medical Center of the Rockies Research

    Loveland, Colorado, 80538, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Cardiovascular Institute

    Hollywood, Florida, 33021, United States

  • Memorial Health Services

    Laguna Hills, California, 92653, United States

  • Mercer University

    Macon, Georgia, 31201, United States

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804, United States

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141, United States

  • Methodist Richardson Medical Center

    Richardson, Texas, 75082, United States

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526, United States

  • North Colorado Medical Center

    Greeley, Colorado, 80631, United States

  • NorthShore University Health System

    Evanston, Illinois, 60201, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018, United States

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701, United States

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106, United States

  • Private Practice Leadership

    Houston, Texas, 77094, United States

  • Providence-Providence Park Hospital

    Southfield, Michigan, 48075, United States

  • Royal Brompton & Harefield NHS Foundation Trust

    Harefield, Middlesex, UB9 6JH, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

  • Sharp Chula Vista Medical Center

    Chula Vista, California, 91991, United States

  • Sharp Grossmont

    Chula Vista, California, 91911, United States

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027, United States

  • St. Alphonsus Medical Center

    Boise, Idaho, 83704, United States

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135, United States

  • St. Francis Hospital - Long Island

    Roslyn, New York, 11576, United States

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136, United States

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Tulane University & Vascular Institute

    New Orleans, Louisiana, 70112, United States

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701, United States

  • UC Irvine Health

    Orange, California, 92868, United States

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of California, San Francisco - Fresno

    Fresno, California, 93701, United States

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Via Christi Research

    Wichita, Kansas, 67214, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • WakeMed

    Raleigh, North Carolina, 27610, United States

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703, United States

  • Washington University

    St Louis, Missouri, 63110, United States

  • WellStar Medical Group

    Marietta, Georgia, 30060, United States

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