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

Heart Failure Clinical Trial

Official title:

First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04203576
• Other study ID #: TF01-CID04
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: Foundry Innovation & Research 1, Limited (FIRE1)
• Contact: Annette Kent
• Phone: 0035319089012
• Email: clinical[@]fire1foundry.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• FIRE1 System
FIRE1 System

Locations

Country	Name	City	State
Czechia	Fakultní Nemocnice Brno	Brno
Czechia	Nemocnice Na Homolce	Prague	Praha 5
Georgia	Israeli-Georgian Medical Research Clinic Helsikor	Tbilisi
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
Ireland	Galway University Hospital	Galway
Netherlands	University Medical Center, Groningen	Groningen	Hanzeplein 1
Netherlands	Erasmus University Medical Center	Rotterdam	Dr. Molewaterplein 40
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Golden Jubilee National Hospital	Glasgow
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	Royal Brompton Hospital Sydney Street	London
United Kingdom	Queen Alexandra Hospital	Portsmouth
United Kingdom	University Hospital Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Foundry Innovation & Research 1, Limited (FIRE1)

Countries where clinical trial is conducted

Czechia,  Georgia,  Ireland,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Secondary Technical Endpoint - Successful transmission of FIRE1 signal.	Successful transmission of a FIRE1 sensor reading from the patient's home.	3 months