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 stable HF patients.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: FIRE1 System

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annette Kent; Phone Number: 0035319089012; Email: clinical@fire1foundry.com

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Recruiting
    • Fakultni Nemocnice Brno
  • Praha 5
    • Prague, Praha 5, Czechia, 150 30
      • Recruiting
      • Nemocnice Na Homolce
• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Israeli-Georgian Medical Research Clinic Helsikor
  • Tbilisi, Georgia
    • Recruiting
    • Tbilisi Heart and Vascular Clinic
• Netherlands
  • Dr. Molewaterplein 40
    • Rotterdam, Dr. Molewaterplein 40, Netherlands, 3015 GD
      • Recruiting
      • Erasmus University Medical Center
  • Hanzeplein 1
    • Groningen, Hanzeplein 1, Netherlands, 9713 GZ
      • Recruiting
      • University Medical Center, Groningen
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Recruiting
    • Royal Bournemouth Hospital
  • Glasgow, United Kingdom, G81 4DY
    • Recruiting
    • Golden Jubilee National Hospital
  • Leicester, United Kingdom, LE3 9QP
    • Recruiting
    • Glenfield Hospital
  • London, United Kingdom, SW3 6NP
    • Recruiting
    • Royal Brompton Hospital Sydney Street
  • Portsmouth, United Kingdom, PO6 3LY
    • Recruiting
    • Queen Alexandra Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • University Hospital Southampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIRE1 System	Device: FIRE1 System; FIRE1 System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications	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.	3 months
Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor	Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound	Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).	3 months
Secondary Technical Endpoint - Successful transmission of FIRE1 signal.	Successful transmission of a FIRE1 sensor reading from the patient's home.	3 months

Collaborators and Investigators

• Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
• Investigators: Study Director: Annette Kent, Clinical Director

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular Disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TF01-CID04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No