First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
- Conditions
- Heart Failure
- Interventions
- Device: FIRE1 System
- Registration Number
- NCT04203576
- Lead Sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FIRE1 System FIRE1 System FIRE1 System
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Secondary Technical Endpoint - Successful transmission of FIRE1 signal. 3 months Successful transmission of a FIRE1 sensor reading from the patient's home.
Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound 3 months Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation).
Trial Locations
- Locations (13)
Nemocnice Na Homolce
🇨🇿Prague, Praha 5, Czechia
Fakultní Nemocnice Brno
🇨🇿Brno, Czechia
Israeli-Georgian Medical Research Clinic Helsikor
🇬🇪Tbilisi, Georgia
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia
Galway University Hospital
🇮🇪Galway, Ireland
Erasmus University Medical Center
🇳🇱Rotterdam, Dr. Molewaterplein 40, Netherlands
University Medical Center, Groningen
🇳🇱Groningen, Hanzeplein 1, Netherlands
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, United Kingdom