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

Foundry Innovation & Research 1 (FIRE1)

Status

Active, not recruiting

Conditions

Heart Failure

Treatments

Device: FIRE1 System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04203576

TF01-CID04

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)