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Clinical Trials in Ireland / NCT04203576
Active, not recruiting

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

NCT04203576 · tracked via the Priya Life Science Ireland tracker
Sponsor
Foundry Innovation & Research 1, Limited (FIRE1)
Phase
N/A
Started
2019-11-22
Last updated
2026-09-03

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Trial sites (13)

FacilityCityRegionStatus
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
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