Could a Pacemaker-Like device ease heart failure?

NCT ID NCT02627196

Disease control Sponsor: CVRx, Inc. Source: ClinicalTrials.gov ↗

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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