ANTHEM-HFrEF Pivotal Study

March 15, 2019

AUTONOMIC REGULATION THERAPY TO ENHANCE MYOCARDIAL FUNCTION AND REDUCE PROGRESSION OF HEART FAILURE WITH REDUCED EJECTION FRACTION (ANTHEM-HFrEF) STUDY

  • Clinical Trial Information

    Trial Contact: Peisner, Pamela

    Trial Phone: 321.843.1037

  • IRB No: 18.092.07

    Protocol Abbrev: ANTHEM-HFrEF

    Principal Investigator: Vijaykumar S Kasi, MD

    Phase: Device: Category B

    Age Group: Adult

    Secondary Protocol No: C-07_CIP_v5.0

    Treatment: Device: VITARIA System Chronic stimulation of the right cervical vagus nerve

    Therapies Involved: Procedural

    ClinicalTrials.gov ID: NCT03425422

  • Objective

    Evaluate Autonomic Regulation Therapy with the VITARIA system in patients with symptomatic heart failure and reduced ejection fraction.

  • Key Eligibility

    1. Age 18 or above
    2. NYHA class III
    3. Left ventricular ejection fraction (EF) ≤ 35%
    4. N-terminal pro-BNP (NT-proBNP) level of at least 800 pg/mL
    5. Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and having a baseline distance of between 150 and 450 meters.