First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

Criteria the registry did not label

• Main Inclusion Criteria
• Adults 18 years or older with heart failure with any of the following in the past 6 months: a decompensation due to heart failure resulting in a heart failure hospitalisation, heart failure treatment in a hospital day-care setting or urgent outpatient heart failure visit
• Receiving treatment in accordance with internationally recognised guidelines.
• Signed patient informed consent form
  • Main Exclusion Criteria:
• Significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol
• Patients with an estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min
• Patients with IVC filter placement in situ, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC
• Patients with implantable ventricular assist device (LVAD, RVAD, BiVAD) in situ
• Patients with Cardiovascular Implantable Electronic Device (CIED) implanted ≤ 3 months prior to enrolment
• Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins (e.g. venous leg ulcers)