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

First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in up to 50 stable HF patients.

Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 6 months. This non-randomised FIH trial will enrol a total of 50 patients and the primary safety and technical endpoints will be assessed at 3 months. Safety measures will include an assessment of all adverse events. Subjects will remain in this study for 24 months.

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)