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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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First In Human Clinical Investigation of the FIRE1 System in Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Device: FIRE1 System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint - Procedural success and freedom from FIRE1 sensor complications | 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. | 3 months | 
| Primary Technical Endpoint - Signal acquisition from the FIRE1 sensor | Technical success defined as signal acquisition immediately post implantation and at an attended clinic visit. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint: Freedom from symptomatic access site thrombosis confirmed by ultrasound | Freedom from symptomatic access site thrombosis confirmed by ultrasound. Freedom from a significant hematoma (defined as requiring intervention, transfusion or prolonging hospitalisation). | 3 months | 
| Secondary Technical Endpoint - Successful transmission of FIRE1 signal. | Successful transmission of a FIRE1 sensor reading from the patient's home. | 3 months | 

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