• Research type

    Research Study

  • Full title

    Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Heart Failure with Reduced Ejection Fraction



  • Contact name

    Ghulam Andre Ng

  • Contact email

  • Sponsor organisation

    Scirent Clinical Research & Science GmbH

  • Identifier


  • Duration of Study in the UK

    5 years, 0 months, 28 days

  • Research summary

    ANTHEM-HFrEF is a worldwide clinical study to test a new treatment for heart failure known as the VITARIA System. This device is designed to improve subjects heart function and to reduce heart failure symptoms by stimulating the vagus nerve, a long nerve from the brain which helps to maintain heart function.
    2 out of 3 subjects will be randomly assigned to have the VITARIA device implanted in addition to their usual stable guideline-directed treatment (dose unchanged for 3 months prior to entering the study). This group of subjects is referred to as the ‘therapy or treatment group’. The remaining subjects will continue their usual stable guideline-directed medical therapy and will be referred to as the control arm or group.
    Subjects in the therapy arm (VITARIA device plus usual guideline-directed treatment), will receive continuous, intermittent, stimulation to the vagus nerve after the surgery is completed, and will undergo visits for the therapy to be increased, or ‘up titrated’, over a period of 3 months. Subjects in the control arm (usual stable guideline-directed medical therapy) will also undergo scheduled visits at a similar frequency as the titration visits that are scheduled for subjects in the therapy arm.
    The study will focus on the safety of the device, its effectiveness in preventing death and heart failure hospitalization, and the effect it may have on improving the heart’s pumping function and reducing heart failure symptoms. Data for safety and efficacy assessments will be collected for both study arms at 4 weeks post-implantation, every 3 months for the first 15/16 months, then every 4 monthly thereafter until the end of the study (up to 5 years).

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    4 Sep 2018

  • REC opinion

    Further Information Favourable Opinion

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