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BeAT-HF: Baroreflex Activation Therapy for Heart Failure

Sponsor
CVRx, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02627196
Collaborator
(none)
1,200
Enrollment
92
Locations
2
Arms
67.4
Anticipated Duration (Months)
13
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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 (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.

Condition or Disease Intervention/Treatment Phase
  • Device: BAROSTIM NEO® System
  • Drug: Medical Management
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure
Actual Study Start Date :
Apr 19, 2016
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Rate of Cardiovascular Mortality and Heart Failure Morbidity [At study completion, approximately 5 years]

    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.

  2. Major Adverse Neurological and Cardiovascular Events (MANCE) [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.

  3. Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) [6 months post implant]

    To demonstrate that treatment with the BAROSTIM NEO® system results in a larger reduction in NT-proBNP at 6 months than medical management.

  4. Six Minute Hall Walk (6MHW) [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

  5. Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) [6 months post implant]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

  1. 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.

  1. Six-minute hall walk (6MHW) ≥ 150 m AND ≤ 400 m within 45 days prior to randomization.

  2. 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Solid organ or hematologic transplant, or currently being actively evaluated for an organ transplant.

  2. Has received or is receiving LVAD therapy.

  3. Has received or is receiving chronic dialysis.

  4. Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.

  5. Primary pulmonary hypertension.

  6. Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).

  7. Severe COPD or severe restrictive lung disease (e.g. requires chronic steroid use or home oxygen use).

  8. Active malignancy.

  9. Current or planned treatment with intravenous positive inotrope therapy.

  10. Life expectancy less than one year.

  11. Clinically significant psychological condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements.

  12. Unable or unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements (e.g. recent drug abuse).

  13. Enrolled and active in another (e.g. device, pharmaceutical, or biological) clinical trial unless approved by the CVRx Clinical department.

  14. Subjects with known allergies to silicone and titanium.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart and Rhythm Solutions, PLLC Chandler Arizona United States 85286
2 Chan Heart Rhythm Institute Mesa Arizona United States 85206
3 Arizona Arrhythmia Research Center Phoenix Arizona United States 85016
4 Phoenix Cardiovascular Research Group Phoenix Arizona United States 85018
5 Cardiovascular Consultants, Ltd. Phoenix Arizona United States 85032
6 Washington Regional Medical Center Fayetteville Arkansas United States 72703
7 Central Cardiology Medical Center Bakersfield California United States 93308
8 Chula Vista Cardiac Center Chula Vista California United States 91910
9 Sharp Grossmont Chula Vista California United States 91911
10 Sharp Chula Vista Medical Center Chula Vista California United States 91991
11 John Muir Health Clinical Research Center Concord California United States 94520
12 University of California, San Francisco - Fresno Fresno California United States 93701
13 Herndon Surgery Center Fresno California United States 93720
14 Glendale Adventist Medical Center Glendale California United States 91204
15 Memorial Health Services Laguna Hills California United States 92653
16 Los Alamitos Cardiovascular Los Alamitos California United States 90720
17 Southern California Permanente Medical Group Los Angeles California United States 90027
18 University of Southern California Los Angeles California United States 90033
19 Advanced Cardiovascular Specialists Mountain View California United States 94040
20 Hoag Memorial Hospital Newport Beach California United States 92663
21 UC Irvine Health Orange California United States 92868
22 Desert Heart Regional Medical Center Palm Springs California United States 92262
23 Huntington Hospital Pasadena California United States 91105
24 Dignity Health Sacramento California United States 95819
25 Adventist Heart Institute Saint Helena California United States 94574
26 University of California San Francisco San Francisco California United States 94143
27 Bonometti, Inc Santa Barbara California United States 93101
28 North Colorado Medical Center Greeley Colorado United States 80631
29 Medical Center of the Rockies Research Loveland Colorado United States 80538
30 Atlantic Clinical Research Center - Cardiology Atlantis Florida United States 33462
31 Clearwater Cardiovascular Consultants Clearwater Florida United States 33756
32 Holy Cross Hospital Fort Lauderdale Florida United States 33308
33 Memorial Cardiovascular Institute Hollywood Florida United States 33021
34 AdventHealth Orlando Orlando Florida United States 32803
35 Avanza Medical Research Center Pensacola Florida United States 32503
36 University of South Florida Tampa Florida United States 33606
37 Mercer University Macon Georgia United States 31201
38 WellStar Medical Group Marietta Georgia United States 30060
39 St. Alphonsus Medical Center Boise Idaho United States 83704
40 NorthShore University Health System Evanston Illinois United States 60201
41 Advocate Medical Group Naperville Illinois United States 60540
42 Prairie Education and Research Cooperative Springfield Illinois United States 62701
43 University of Kansas Medical Center Research Institute, Inc. Kansas City Kansas United States 66160
44 Via Christi Research Wichita Kansas United States 67214
45 Baptist Health Lexington Lexington Kentucky United States 40503
46 University of Kentucky Lexington Kentucky United States 40536
47 Cardiovascular Institute of the South Houma Louisiana United States 70360
48 Tulane University & Vascular Institute New Orleans Louisiana United States 70112
49 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
50 St. Elizabeth's Medical Center Brighton Massachusetts United States 02135
51 Detroit Medical Center Cardiovascular Institute Detroit Michigan United States 48201
52 Ascension St. Mary's Research Institute Saginaw Michigan United States 48602
53 Providence-Providence Park Hospital Southfield Michigan United States 48075
54 University of Mississippi Medical Center Jackson Mississippi United States 39216
55 Washington University Saint Louis Missouri United States 63110
56 St. Louis Heart and Vascular Saint Louis Missouri United States 63136
57 Mercy Hospital St. Louis Saint Louis Missouri United States 63141
58 Mercy Hospital Springfield Springfield Missouri United States 65804
59 Nebraska Heart Institute Lincoln Nebraska United States 68526
60 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
61 Healthcare Partners Clinical Research Las Vegas Nevada United States 89169
62 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
63 Hackensack University Medical Center Hackensack New Jersey United States 07601
64 Presbyterian Heart Group Albuquerque New Mexico United States 87106
65 University of Rochester Rochester New York United States 14642
66 St. Francis Hospital - Long Island Roslyn New York United States 11576
67 Cone Health Greensboro North Carolina United States 27401
68 WakeMed Raleigh North Carolina United States 27610
69 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
70 The Christ Hospital Cincinnati Ohio United States 45219
71 Ohio State University Columbus Ohio United States 43210
72 Oklahoma Cardiovascular Research Group Oklahoma City Oklahoma United States 73120
73 Oregon Health & Science University Portland Oregon United States 97239
74 Drexel University Philadelphia Pennsylvania United States 19102
75 Allegheny-Singer Research Institute Pittsburgh Pennsylvania United States 15212
76 Medical University of South Carolina Charleston South Carolina United States 29425
77 McLeod Cardiology Associates Florence South Carolina United States 29506
78 Stern Cardiovascular Foundation Germantown Tennessee United States 38138
79 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78705
80 Cardiovascular Research Institute of Dallas Dallas Texas United States 75231
81 Private Practice Leadership Houston Texas United States 77094
82 Methodist Richardson Medical Center Richardson Texas United States 75082
83 Tyler Cardiovascular Consultants Tyler Texas United States 75701
84 Intermountain Heart Institute Murray Utah United States 84107
85 University of Utah Salt Lake City Utah United States 84132
86 Virginia Mason Medical Center Seattle Washington United States 98101
87 CHI Franciscan Health Research Center Tacoma Washington United States 98405
88 Columbia St. Mary's Hospital Milwaukee Wisconsin United States 53211
89 Royal Papworth Hospital NHS Foundation Trust Cambridge Cambridgeshire United Kingdom CB23 3RE
90 Liverpool Heart and Chest Hospital Liverpool Merseyside United Kingdom L14 3PE
91 Royal Brompton & Harefield NHS Foundation Trust Harefield Middlesex United Kingdom UB9 6JH
92 Belfast Health & Social Care Trust Belfast Northern Ireland United Kingdom BT9 7AB

Sponsors and Collaborators

  • CVRx, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT02627196
Other Study ID Numbers:
  • 360043-001
First Posted:
Dec 10, 2015
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Dec 17, 2020