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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications — 3 months The primary, composite endpoint is success of the FIRE1 sensor, which includes procedural success defined as sensor deployment at the intended site without acute device or procedural related complications and freedom from sensor complications including device migration, clinically significant fracture and/ or clinically significant perforation of the Inferior Vena Cava (IVC) or symptomatic caval thrombosis.
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor — 3 months Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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