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Heart FailureBeAT-HFNCT02627196

Baroreflex Activation Therapy for Heart Failure

A study testing BAROSTIM NEO® System and Medical Management in people with Heart Failure, run by CVRx, Inc. at 92 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure
What is being tested?
BAROSTIM NEO® System and Medical Management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,090 participants
Where
92 sitesin 2 countries
Study dates
19 Apr 2016to Oct 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21 years or above.
  • 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).
  • Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
  • 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.
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  • 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.
  • 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.
  • Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to randomization.
  • 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:
  • Below the level of the mandible AND
  • No ulcerative carotid arterial plaques AND
  • No carotid atherosclerosis producing a 50% or greater reduction in linear diameter in the internal carotid AND
  • 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.
  • 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.
  • 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.
  • 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.
  • Signed a CVRx-approved informed consent form for participation in this trial.

Who cannot join

  • If any of the following criteria are met, subjects are not eligible for this trial.
  • Received cardiac resynchronization therapy (CRT) within six months of randomization, or is actively receiving CRT.
  • 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. ,
  • Known or suspected baroreflex failure or autonomic neuropathy.
  • AHA/ACC Stage D heart failure within 45 days prior to randomization.
  • Body mass index > 40.
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  • Serum estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m2 within 45 days prior to randomization.
  • 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.)
  • Recurring symptomatic hypotension within 45 days prior to randomization.
  • Significant uncontrolled symptomatic bradyarrhythmias or unstable ventricular arrhythmias.
  • 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.
  • Episode of NYHA class IV heart failure with acute pulmonary edema within 45 days prior to randomization.
  • 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
  • Solid organ or hematologic transplant, or currently being actively evaluated for an organ transplant.
  • Has received or is receiving LVAD therapy.
  • Has received or is receiving chronic dialysis.
  • Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.
  • Primary pulmonary hypertension.
  • Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).
  • Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use).
  • Active malignancy.
  • Current or planned treatment with intravenous positive inotrope therapy.
  • Life expectancy less than one year.
  • Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.
  • Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements (e.g. recent drug abuse).
  • Enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical trial unless approved by the CVRx Clinical department.
  • Subjects with known allergies to silicone and titanium.

Trial locations and contacts

92 sites in 2 countries.

92 sites in 2 countries

United States88 sites

  • Presbyterian Heart Group

    Albuquerque, New Mexico, 87106

  • Atlantic Clinical Research Center - Cardiology

    Atlantis, Florida, 33462

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Central Cardiology Medical Center

    Bakersfield, California, 93308

  • St. Alphonsus Medical Center

    Boise, Idaho, 83704

  • St. Elizabeth's Medical Center

    Brighton, Massachusetts, 02135

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Heart and Rhythm Solutions, PLLC

    Chandler, Arizona, 85286

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chula Vista Cardiac Center

    Chula Vista, California, 91910

  • Sharp Grossmont

    Chula Vista, California, 91911

  • Sharp Chula Vista Medical Center

    Chula Vista, California, 91991

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Ohio State University

    Columbus, Ohio, 43210

  • John Muir Health Clinical Research Center

    Concord, California, 94520

  • Cardiovascular Research Institute of Dallas

    Dallas, Texas, 75231

  • Detroit Medical Center Cardiovascular Institute

    Detroit, Michigan, 48201

  • NorthShore University Health System

    Evanston, Illinois, 60201

  • Washington Regional Medical Center

    Fayetteville, Arkansas, 72703

  • McLeod Cardiology Associates

    Florence, South Carolina, 29506

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • University of California, San Francisco - Fresno

    Fresno, California, 93701

  • Herndon Surgery Center

    Fresno, California, 93720

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Glendale Adventist Medical Center

    Glendale, California, 91204

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Cone Health

    Greensboro, North Carolina, 27401

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Cardiovascular Institute

    Hollywood, Florida, 33021

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Private Practice Leadership

    Houston, Texas, 77094

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center Research Institute, Inc.

    Kansas City, Kansas, 66160

  • Memorial Health Services

    Laguna Hills, California, 92653

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Healthcare Partners Clinical Research

    Las Vegas, Nevada, 89169

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Los Alamitos Cardiovascular

    Los Alamitos, California, 90720

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • University of Southern California

    Los Angeles, California, 90033

  • Medical Center of the Rockies Research

    Loveland, Colorado, 80538

  • Mercer University

    Macon, Georgia, 31201

  • WellStar Medical Group

    Marietta, Georgia, 30060

  • Chan Heart Rhythm Institute

    Mesa, Arizona, 85206

  • Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • Advanced Cardiovascular Specialists

    Mountain View, California, 94040

  • Intermountain Heart Institute

    Murray, Utah, 84107

  • Advocate Medical Group

    Naperville, Illinois, 60540

  • Tulane University & Vascular Institute

    New Orleans, Louisiana, 70112

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • UC Irvine Health

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Desert Heart Regional Medical Center

    Palm Springs, California, 92262

  • Huntington Hospital

    Pasadena, California, 91105

  • Avanza Medical Research Center

    Pensacola, Florida, 32503

  • Drexel University

    Philadelphia, Pennsylvania, 19102

  • Arizona Arrhythmia Research Center

    Phoenix, Arizona, 85016

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Cardiovascular Consultants, Ltd.

    Phoenix, Arizona, 85032

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • WakeMed

    Raleigh, North Carolina, 27610

  • Methodist Richardson Medical Center

    Richardson, Texas, 75082

  • University of Rochester

    Rochester, New York, 14642

  • St. Francis Hospital - Long Island

    Roslyn, New York, 11576

  • Dignity Health

    Sacramento, California, 95819

  • Ascension St. Mary's Research Institute

    Saginaw, Michigan, 48602

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California San Francisco

    San Francisco, California, 94143

  • Bonometti, Inc

    Santa Barbara, California, 93101

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Providence-Providence Park Hospital

    Southfield, Michigan, 48075

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Washington University

    St Louis, Missouri, 63110

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Adventist Heart Institute

    St. Helena, California, 94574

  • CHI Franciscan Health Research Center

    Tacoma, Washington, 98405

  • University of South Florida

    Tampa, Florida, 33606

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Via Christi Research

    Wichita, Kansas, 67214

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom4 sites

  • Belfast Health & Social Care Trust

    Belfast, Northern Ireland, BT9 7AB

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB23 3RE

  • Royal Brompton & Harefield NHS Foundation Trust

    Harefield, Middlesex, UB9 6JH

  • Liverpool Heart and Chest Hospital

    Liverpool, Merseyside, L14 3PE

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Conditions
Heart Failure
Being tested
BAROSTIM NEO® System, Medical Management
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAROSTIM NEO® SystemDevice

  • Medical ManagementDrug

Study groups in NCT02627196
Study groupRoleWhat they receive
Device and Medical ManagementExperimentalSubjects 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.
Receives: Device: BAROSTIM NEO® System; Drug: Medical Management
Medical ManagementActive comparatorSubjects 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.
Receives: Drug: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Cardiovascular Mortality and Heart Failure Morbidity

    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.

    Measured: From randomization until data-cut date for the endpoint analysis. Median follow-up was 3.6 years per patient.

  2. Major Adverse Neurological and Cardiovascular Events (MANCE)

    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.

    Measured: 6 months post implant

  3. Percent Change in Log 10 Amino-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) From Baseline to 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.

    Measured: 6 months post-implant

  4. Change to Six Minute Hall Walk (6MHW)

    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.

    Measured: Baseline and 6 months post-implant

  5. Change in Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) Score

    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.

    Measured: Baseline and 6 months post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study start19 Apr 2016
  3. Primary completionOct 2023
  4. Study completionOct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,090 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02627196
Sponsor's protocol ID
360043-001
Acronym
BeAT-HF
Status last verified
Feb 2026
First submitted
7 Dec 2015
Last updated
10 Mar 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Fu Q, Zhang R, Witkowski S, Arbab-Zadeh A, Prasad A, Okazaki K, Levine BD. Persistent sympathetic activation during chronic antihypertensive therapy: a potential mechanism for long term morbidity? Hypertension. 2005 Apr;45(4):513-21. doi: 10.1161/01.HYP.0000158312.63381.c1. Epub 2005 Feb 28.

    PubMed 15738344

  • Esler M, Kaye D. Increased sympathetic nervous system activity and its therapeutic reduction in arterial hypertension, portal hypertension and heart failure. J Auton Nerv Syst. 1998 Oct 15;72(2-3):210-9. doi: 10.1016/s0165-1838(98)00107-6.

    PubMed 9851571

  • Sleight P. The importance of the autonomic nervous system in health and disease. Aust N Z J Med. 1997 Aug;27(4):467-73. doi: 10.1111/j.1445-5994.1997.tb02220.x.

    PubMed 9448899

  • Peters TK, Koralewski HE, Zerbst E. Blood pressure and heart rate changes during physical activity upon heart rate feedback-controlled electrical carotid sinus nerve stimulation. Int J Cardiol. 1989 Mar;22(3):389-92. doi: 10.1016/0167-5273(89)90281-7.

    PubMed 2785088

  • Georgakopoulos D, Wagner D, Cates AW, Irwin E, Lovett EG. Effects of electrical stimulation of the carotid sinus baroreflex using the Rheos device on ventricular-vascular coupling and myocardial efficiency assessed by pressure-volume relations in non-vagotomized anesthetized dogs. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:2025-9. doi: 10.1109/IEMBS.2009.5334421.

    PubMed 19964769

  • Sabbah HN, Gupta RC, Imai M, Irwin ED, Rastogi S, Rossing MA, Kieval RS. Chronic electrical stimulation of the carotid sinus baroreflex improves left ventricular function and promotes reversal of ventricular remodeling in dogs with advanced heart failure. Circ Heart Fail. 2011 Jan;4(1):65-70. doi: 10.1161/CIRCHEARTFAILURE.110.955013. Epub 2010 Nov 19.

    PubMed 21097604

  • Zucker IH, Hackley JF, Cornish KG, Hiser BA, Anderson NR, Kieval R, Irwin ED, Serdar DJ, Peuler JD, Rossing MA. Chronic baroreceptor activation enhances survival in dogs with pacing-induced heart failure. Hypertension. 2007 Nov;50(5):904-10. doi: 10.1161/HYPERTENSIONAHA.107.095216. Epub 2007 Sep 10.

    PubMed 17846349

  • Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.

    PubMed 26011593

  • Weaver FA, Abraham WT, Little WC, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Madershahian N, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Zile MR. Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. Semin Thorac Cardiovasc Surg. 2016 Summer;28(2):320-328. doi: 10.1053/j.semtcvs.2016.04.017. Epub 2016 Jun 2.

    PubMed 28043438

  • Ferreira JP, Duarte K, Graves TL, Zile MR, Abraham WT, Weaver FA, Lindenfeld J, Zannad F. Natriuretic Peptides, 6-Min Walk Test, and Quality-of-Life Questionnaires as Clinically Meaningful Endpoints in HF Trials. J Am Coll Cardiol. 2016 Dec 20;68(24):2690-2707. doi: 10.1016/j.jacc.2016.09.936.

    PubMed 27978953

  • Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.

    PubMed 25982108

  • Gronda E, Francis D, Zannad F, Hamm C, Brugada J, Vanoli E. Baroreflex activation therapy: a new approach to the management of advanced heart failure with reduced ejection fraction. J Cardiovasc Med (Hagerstown). 2017 Sep;18(9):641-649. doi: 10.2459/JCM.0000000000000544.

    PubMed 28737621

  • Gronda E, Seravalle G, Brambilla G, Costantino G, Casini A, Alsheraei A, Lovett EG, Mancia G, Grassi G. Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. Eur J Heart Fail. 2014 Sep;16(9):977-83. doi: 10.1002/ejhf.138. Epub 2014 Jul 28.

    PubMed 25067799

  • Zile MR, Claggett BL, Prescott MF, McMurray JJ, Packer M, Rouleau JL, Swedberg K, Desai AS, Gong J, Shi VC, Solomon SD. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2425-2436. doi: 10.1016/j.jacc.2016.09.931.

    PubMed 27908347

  • Cleland JG, McMurray JJ, Kjekshus J, Cornel JH, Dunselman P, Fonseca C, Hjalmarson A, Korewicki J, Lindberg M, Ranjith N, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J; CORONA Study Group. Plasma concentration of amino-terminal pro-brain natriuretic peptide in chronic heart failure: prediction of cardiovascular events and interaction with the effects of rosuvastatin: a report from CORONA (Controlled Rosuvastatin Multinational Trial in Heart Failure). J Am Coll Cardiol. 2009 Nov 10;54(20):1850-9. doi: 10.1016/j.jacc.2009.06.041.

    PubMed 19892235

Questions about this trial

What is this clinical trial studying?

A study testing BAROSTIM NEO® System and Medical Management in people with Heart Failure, run by CVRx, Inc. at 92 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02627196, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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