Baroreflex Activation Therapy for Heart Failure (BeAT-HF)

March 6, 2026 updated by: CVRx, Inc.

Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

The purpose of this clinical trial (NCT02627196) is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III, left ventricular ejection fraction (LVEF) ≤ 35% and NT-proBNP<1600 pg/ml despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

The total trial duration is anticipated to be approximately 5 years; however, the duration of an individual subject enrollment will depend on when he or she entered the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant). The trial will be conducted at up to 120 investigational centers in the U.S. and up to 20 investigational centers outside the U.S. These centers will enroll up to 1200 subjects to randomize approximately 480 subjects who meet the entry criteria.

For all subjects, trial visits will occur at 0.5, 1, 1.5, 2, 3, 6, 9 and 12 months post-implant (post anticipated implant for medical management). Visits will occur quarterly from 15 to 24 months and semi-annually thereafter.

Subjects are followed in an identical manner regardless of trial arm.

The data will provide evidence of the safety and efficacy of BAROSTIM THERAPY. The accumulated morbidity and mortality data collected will provide evidence of morbidity and mortality benefit. This trial will involve one or more interim analyses to evaluate when sufficient evidence is reached for the final morbidity and mortality analysis.

Study Type

Interventional

Enrollment (Actual)

1090

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Royal Papworth Hospital NHS Foundation Trust
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Royal Brompton & Harefield NHS Foundation Trust
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7AB
        • Belfast Health & Social Care Trust
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • Heart and Rhythm Solutions, PLLC
      • Mesa, Arizona, United States, 85206
        • Chan Heart Rhythm Institute
      • Phoenix, Arizona, United States, 85016
        • Arizona Arrhythmia Research Center
      • Phoenix, Arizona, United States, 85018
        • Phoenix Cardiovascular Research Group
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants, Ltd.
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Washington Regional Medical Center
    • California
      • Bakersfield, California, United States, 93308
        • Central Cardiology Medical Center
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Chula Vista, California, United States, 91911
        • Sharp Grossmont
      • Chula Vista, California, United States, 91991
        • Sharp Chula Vista Medical Center
      • Concord, California, United States, 94520
        • John Muir Health Clinical Research Center
      • Fresno, California, United States, 93701
        • University of California, San Francisco - Fresno
      • Fresno, California, United States, 93720
        • Herndon Surgery Center
      • Glendale, California, United States, 91204
        • Glendale Adventist Medical Center
      • Laguna Hills, California, United States, 92653
        • Memorial Health Services
      • Los Alamitos, California, United States, 90720
        • Los Alamitos Cardiovascular
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90027
        • Southern California Permanente Medical Group
      • Mountain View, California, United States, 94040
        • Advanced Cardiovascular Specialists
      • Newport Beach, California, United States, 92663
        • Hoag Memorial Hospital
      • Orange, California, United States, 92868
        • UC Irvine Health
      • Palm Springs, California, United States, 92262
        • Desert Heart Regional Medical Center
      • Pasadena, California, United States, 91105
        • Huntington Hospital
      • Sacramento, California, United States, 95819
        • Dignity Health
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Santa Barbara, California, United States, 93101
        • Bonometti, Inc
      • St. Helena, California, United States, 94574
        • Adventist Heart Institute
    • Colorado
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Loveland, Colorado, United States, 80538
        • Medical Center of the Rockies Research
    • Florida
      • Atlantis, Florida, United States, 33462
        • Atlantic Clinical Research Center - Cardiology
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Cardiovascular Institute
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
      • Pensacola, Florida, United States, 32503
        • Avanza Medical Research Center
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Macon, Georgia, United States, 31201
        • Mercer University
      • Marietta, Georgia, United States, 30060
        • WellStar Medical Group
    • Idaho
      • Boise, Idaho, United States, 83704
        • St. Alphonsus Medical Center
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Health System
      • Naperville, Illinois, United States, 60540
        • Advocate Medical Group
      • Springfield, Illinois, United States, 62701
        • Prairie Education And Research Cooperative
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center Research Institute, Inc.
      • Wichita, Kansas, United States, 67214
        • Via Christi Research
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • Tulane University & Vascular Institute
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center Cardiovascular Institute
      • Saginaw, Michigan, United States, 48602
        • Ascension St. Mary's Research Institute
      • Southfield, Michigan, United States, 48075
        • Providence-Providence Park Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63110
        • Washington University
      • St Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, United States, 89169
        • Healthcare Partners Clinical Research
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Presbyterian Heart Group
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital - Long Island
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Cone Health
      • Raleigh, North Carolina, United States, 27610
        • WakeMed
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Cardiovascular Research Group
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny-Singer Research Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Florence, South Carolina, United States, 29506
        • McLeod Cardiology Associates
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Stern Cardiovascular Foundation
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, United States, 75231
        • Cardiovascular Research Institute of Dallas
      • Houston, Texas, United States, 77094
        • Private Practice Leadership
      • Richardson, Texas, United States, 75082
        • Methodist Richardson Medical Center
      • Tyler, Texas, United States, 75701
        • Tyler Cardiovascular Consultants
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Heart Institute
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • CHI Franciscan Health Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • Columbia St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device and Medical Management
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Device: BAROSTIM NEO® System
Drug: Medical Management
Active Comparator: Medical Management
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Drug: Medical Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Neurological and Cardiovascular Events (MANCE)
Time Frame: 6 months post implant
To demonstrate the safety of the Barostim NEO® System via the event-free rate of all system- and procedure-related Major Adverse Neurological and Cardiovascular Events (MANCE) occurring within 6 months post implant in the device arm.
6 months post implant
Rate of Cardiovascular Mortality and Heart Failure Morbidity
Time Frame: From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.

To demonstrate that treatment with the BAROSTIM NEO® System, relative to medical management, reduces the rate of cardiovascular mortality or worsening heart failure that leads to hospitalization, cardiac assist device or heart transplant.

Event rates were calculated using negative binomial to account for varying follow-up times. Rates are expressed as events per patient-year, with 95% confidence intervals reflecting dispersion.
From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.
Percent Change in Log 10 Amino-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) From Baseline to 6 Months Post-implant
Time Frame: 6 months post-implant
To demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP from baseline to 6 months post-implant than medical management.
6 months post-implant
Change to Six Minute Hall Walk (6MHW)
Time Frame: Baseline and 6 months post-implant

To demonstrate that treatment with the BAROSTIM NEO® system results in a larger improvement in 6MHW at 6 months than medical management.

The 6 Minute Hall Walk is an assessment of a patient's functional exercise capacity by recording the maximum distance walked in 6 minutes on a flat course in meters (m). A higher score (more distance) indicates better functional capacity.
Baseline and 6 months post-implant
Change in Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) Score
Time Frame: Baseline and 6 months post-implant

To demonstrate that treatment with the BAROSTIM NEO® System results in a larger improvement in MLWHF QOL score at 6 months than medical management.

The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-reported outcome measure assessing the impact of heart failure on quality of life. It includes 21 items rated from 0 to 5 (0 = no impact, 5 = very much impact). The Total Score is the sum of all items and ranges from 0 to 105, with higher scores indicating worse quality of life.
Baseline and 6 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Study Chair: Michael Zile, MD, Medical University of South Carolina
  • Principal Investigator: Faiez Zannad, MD, Inserm Centre d'Investigation, CHU de Nancy
  • Principal Investigator: JoAnn Lindenfield, MD, Vanderbilt Heart and Vascular Institute
  • Principal Investigator: William Abraham, MD, Ohio State University
  • Principal Investigator: Fred Weaver, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2016

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

December 7, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimated)

December 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360043-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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