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

  • End date
    Apr 28, 2022
  • participants needed
  • sponsor
    Foundry Innovation & Research 1, Limited (FIRE1)
Updated on 17 February 2021


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


Eligible patients must be stable HF patients, NYHA class III who were hospitalised/treated for an episode of worsening HF within the last 12 months. This non-randomised FIH trial will enrol a total of 10 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 on this study for 24 months.

Condition Heart Failure NYHA Class III
Treatment FIRE1 System
Clinical Study IdentifierNCT04203576
SponsorFoundry Innovation & Research 1, Limited (FIRE1)
Last Modified on17 February 2021


Yes No Not Sure

Inclusion Criteria

Adults 18 years or older with NYHA Class III heart failure with any of the following in the past 12 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
Diagnosis of heart failure and receiving heart failure medical therapy for > 3 months
On stable optimized HF therapy
Signed patient informed consent form

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) or prosthetic valves in situ
Patients with Cardiac Resynchronization Device (CRT) or implantable cardioverter-defibrillator (ICD) 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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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