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

Main Inclusion Criteria

• Adults 18 years or older with heart failure with any of the following in the past 6months: a decompensation due to heart failure resulting in a heart failurehospitalisation, heart failure treatment in a hospital day-care setting or urgentoutpatient 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 theclinical 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 anatomyor known congenital malformation or absence of IVC or occlusive or free-floatingthrombus in the IVC

• Patients with implantable ventricular assist device (LVAD, RVAD, BiVAD) in situ

• Patients with Cardiovascular Implantable Electronic Device (CIED) implanted ≤ 3months prior to enrolment

• Patients with conditions associated with occlusion of the IVC, iliac or commonfemoral veins (e.g. venous leg ulcers)