Clinical trial NCT04203576: First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
Official title: First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Cardiovascular Disease
Lead sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
Sponsor class: INDUSTRY
First posted: 2019-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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 outcomes:
measure: Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications
timeFrame: 3 months
measure: Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound
timeFrame: 3 months
measure: Secondary Technical Endpoint - Successful transmission of FIRE1 signal.
timeFrame: 3 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
state: Praha 5
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsikor
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Galway
country: Ireland
facility: Galway University Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Dr. Molewaterplein 40
city: Groningen
country: Netherlands
facility: University Medical Center, Groningen
state: Hanzeplein 1
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital Sydney Street
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Clinical Director
name: Annette Kent
role: STUDY_DIRECTOR
References: