First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)
Study Details
Study Description
Brief Summary
First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Eligible patients must be stable HF patients, NYHA class III who were hospitalised/treated for an episode of worsening HF within the last 12 months. This non-randomised FIH trial will enrol a total of 10 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 on this study for 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FIRE1 System FIRE1 System |
Device: FIRE1 System
FIRE1 System
|
Outcome Measures
Primary Outcome Measures
- 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
- 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).
- Secondary Technical Endpoint - Successful transmission of FIRE1 signal. [4 months]
Successful transmission of a FIRE1 sensor reading from the patient's home. Signal acquisition during fluid loading procedure.
Eligibility Criteria
Criteria
Main Inclusion Criteria
-
Adults 18 years or older with NYHA Class III heart failure with any of the following in the past 12 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
-
Diagnosis of heart failure and receiving heart failure medical therapy for > 3 months
-
On stable optimized HF therapy
-
Signed patient informed consent form
Main Exclusion Criteria:
-
Significant comorbidity that would interfere with the ability to safely complete the clinical investigation protocol
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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) or prosthetic valves in situ
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Patients with Cardiac Resynchronization Device (CRT) or implantable cardioverter-defibrillator (ICD) implanted ≤ 3 months prior to enrolment
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Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins (e.g. venous leg ulcers)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nemocnice Na Homolce | Prague | Praha 5 | Czechia | 150 30 |
| 2 | FakultnĂ Nemocnice Brno | Brno | Czechia | 625 00 |
Sponsors and Collaborators
- Foundry Innovation & Research 1, Limited (FIRE1)
Investigators
- Study Director: Annette Kent, Clinical Director
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TF01-CID04