Clinical Trials in Ireland / NCT04203576
Active, not recruiting
Not applicable
First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
NCT04203576 · tracked via the Priya Life Science Ireland tracker
Condition(s) studied
Heart Failure
Investigational drug(s) / intervention(s)
FIRE1 System
FIRE1 System: FIRE1 System
Study 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.
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)
Primary outcome measure(s)
- 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.
Trial sites (13)
| Facility | City | Region | Status |
|---|---|---|---|
| Nemocnice Na Homolce | Prague | Praha 5 | |
| 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 | |
| University Medical Center, Groningen | Groningen | Hanzeplein 1 | |
| 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 |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04203576 on ClinicalTrials.gov ↗ ← All trials in Ireland