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Barostim Therapy for Heart Failure (BeAT-HF)

This study is currently recruiting participants.
Verified October 2017 by CVRx, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02627196
First Posted: December 10, 2015
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
CVRx, Inc.
  Purpose
The purpose of this trial 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 and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

Condition Intervention
Heart Failure Device: BAROSTIM NEO® System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Official Title: Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Rate of Cardiovascular Mortality and Heart Failure Morbidity [ Time Frame: 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.

  • 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.

  • Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP) [ Time Frame: 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.

  • Six Minute Hall Walk (6MHW) [ Time Frame: 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

  • Minnesota Living With Heart Failure Quality of Life (MLWHF QOL) [ Time Frame: 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


Estimated Enrollment: 800
Actual Study Start Date: April 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Arm
Subjects will receive Barostim Activation Therapy® with the implanted BAROSTIM NEO® System in addition to optimal guideline directed medical management.
Device: BAROSTIM NEO® System
No Intervention: Guideline Directed Medical Management
Patients will be followed under optimal guideline directed medical management.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Currently NYHA Class II or III heart failure.
  2. Left ventricular ejection fraction ≤ 35% within 45 days prior to randomization.
  3. Heart failure accompanied by a BNP ≥ 100 or NT-proBNP ≥ 400 within 45 days prior to randomization, or a heart failure hospitalization in the past 12 months
  4. 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.
  5. Six-minute hall walk (6MHW) ≥ 150m AND ≤ 400m within 45 days prior to randomization.
  6. The artery planned for the BAROSTIM implant must have:

    • 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
      • Has no ulcerative carotid arterial plaques
      • Has no carotid atherosclerosis producing at 50% or greater reduction in linear diameter of the internal carotid
      • Has no carotid atherosclerosis producing at 50% or greater reduction in linear diameter of the distal common carotid
    • No prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region.
  7. If female and of childbearing potential, must use a medically accepted method of birth control and have a negative pregnancy test within 14 days of randomization.
  8. Received a standard cardiac work up and is an appropriate candidate for the study and the surgical procedure as determine by a trial cardiologist and trial surgeon.
  9. Subjects implanted with a cardiac rhythm management device that does not utilize an intracardiac lead, or implanted with a neurostimulation device, must be approved prior to enrollment.
  10. Signed a CVRx-approved informed consent form for participation in this trial.

Exclusion Criteria:

  1. Received cardiac resynchronization therapy (CRT) within 6 months of randomization, or is actively receiving CRT.
  2. Currently have a Class I indication for a cardiac resynchronization therapy (CRT) device according to the American Heart Association/American College of Cardiology/European Society of Cardiology (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. BMI > 40.
  6. Serum estimated glomerular filtration rate (eGFR) < 25 mL/min/173m^2 within 45 days prior to randomization.
  7. Recurring resting heart rate of either < 60 beats per minute(bpm) or > 100 bpm via clinic measurements within 45 days prior to randomization. (Heart rate of < 60bpm 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.
  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
    • 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 left ventricular assist device (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.
  19. Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
  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.
  25. Enrolled and active in another clinical trial (unless previously approved by the CVRx Clinical Department).
  26. Subjects with known allergies to silicone and titanium
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627196


Contacts
Contact: Liz Galle 763-416-2876 lgalle@cvrx.com

  Show 93 Study Locations
Sponsors and Collaborators
CVRx, Inc.
  More Information

Additional Information:
Publications:

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02627196     History of Changes
Other Study ID Numbers: 360043-001
First Submitted: December 7, 2015
First Posted: December 10, 2015
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by CVRx, Inc.:
Heart Failure
BAROSTIM NEO®
Baroreceptor
Baroreflex
Baroreflex Activation Therapy™
New York Heart Associate Class III Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases