Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion with Feraheme in Iron Deficient Patients with durable Ventricular Assist Device support

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Heart Failure, Unspecified
  • Age: Between 19 years - 110 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have at least stable clinical status for >30days after placement of durable ventricular assist device
    2. Subject's blood test results meets the requirements as per the protocol
    3. Subjects must be able and willing to provide written informed consent

You may not be eligible for this study if the following are true:

    1. Subjects with known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
    2. Subjects with history of anaphylaxis
    3. Subjects treated with erythropoiesis stimulating agent or intravenous iron in last 3 months
    4. Those who had renal failure on hemodialysis
    5. Subjects with respiratory failure on mechanical ventilation
    6. Subjects who had disabling Stroke
    7. Subjects with ventricular assist device thrombosis
    8. Subjects with evidence of active gastrointestinal bleeding or other active blood loss
    9. Subjects who were hospitalized <30 days
    10. Pregnant or breastfeeding females

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.