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

Overview

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.

Full Title of Study: “First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2021

Detailed Description

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.

Interventions

  • Device: FIRE1 System
    • FIRE1 System

Arms, Groups and Cohorts

  • Experimental: FIRE1 System
    • FIRE1 System

Clinical Trial Outcome Measures

Primary Measures

  • Primary Safety Endpoint – Procedural success and freedom from FIRE1 sensor complications
    • Time Frame: 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
    • Time Frame: 3 months
    • Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.

Secondary Measures

  • Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
    • Time Frame: 3 months
    • Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).
  • Secondary Technical Endpoint – Successful transmission of FIRE1 signal.
    • Time Frame: 4 months
    • Successful transmission of a FIRE1 sensor reading from the patient’s home. Signal acquisition during fluid loading procedure.

Participating in This Clinical Trial

Main 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 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) 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Foundry Innovation & Research 1, Limited (FIRE1)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Annette Kent, Study Director, Clinical Director
  • Overall Contact(s)
    • Annette Kent, 0035319089012, clinical@fire1foundry.com

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