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.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
FIRE1 System
Nemocnice Na Homolce
Prague, Praha 5, Czechia
Fakultní Nemocnice Brno
Brno, Czechia
Israeli-Georgian Medical Research Clinic Helsikor
Tbilisi, Georgia
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.
Time frame: 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.
Time frame: 3 months
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).
Time frame: 3 months
Secondary Technical Endpoint - Successful transmission of FIRE1 signal.
Successful transmission of a FIRE1 sensor reading from the patient's home.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 3 more locations