Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)

Study Overview
=================
Brief Summary
-----------------
Early Feasibility Study of the FIRE1™ System in Heart Failure Patients to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients

Detailed Description
-----------------
Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 12 months. This non-randomised trial will enroll up to 15 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.

Official Title
-----------------
Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: FIRE1 System


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria Adults 18 years or older Patients meeting diagnostic criteria for heart failure diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC guidelines regardless of ejection fraction as evidenced by: A heart failure decompensation resulting in a hospitalisation or heart failure failure related treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administrator of an intravenous diuretic up to 12 months prior to enrolment and Chronic heart failure, as evidenced by a screening B-type natriuretic peptide (BNP) ≥300 pg/mL or N-terminal-pro-B type natriuretic peptide (NT-proBNP) ≥1000 pg/mL, or BNP ≥500 pg/mL or NT-proBNP ≥1,600 pg/mL for subjects presenting with atrial fibrillation at screening. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the 4 weeks prior to screening only NT-proBNP values should be considered, and Patients must also be on a daily oral loop diuretic dose of 40mg or greater furosemide equivalents for the 2 weeks prior to screening. Signed patient informed consent form Main Exclusion Criteria: Significant comorbidity that, in the investigator's opinion, would results in the patient being unable to safely undergo the procedure or participate in the clinical investigation. Patients with an estimated Glomerular Filtration Rate (eGFR) < 25 ml/min/1.73m2 Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC. Patients who have severe right sided valvular disease or a right sided mechanical valve. Patients with a cardiac resynchronization therapy device implanted ≤ 3 months to prior to screening. Patients who have undergone invasive cardiac surgery in the 3 months prior to screening. Patients who have undergone percutaneous valve / structural heart intervention in in the 3 months prior to screening. Patients who have received heart transplant or a ventricular assist device or planned for advanced therapies within the next year. Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FIRE1 System<br>FIRE1 System | Device: FIRE1 System<br>* FIRE1 System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Procedural success | Procedural success defined as Sensor deployment at the intended site without procedural related SAEs | 30 days | 
| Primary Safety Endpoint - Freedom from Sensor Complications | 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 | 3 months | 
| Primary Effectiveness Endpoint - Device Performance | Device performance defined as an assessment of the ability of the FIRE1™ System to successfully transmit collected data to a secure database | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory Safety Outcome | Summary of all device / system related adverse events (AEs) | 24 months | 
| Exploratory Safety Outcome | Summary of all device / system related complications | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Disease