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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05763407
• Other study ID #: TF03-CID02
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Foundry Innovation & Research 1, Limited (FIRE1)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: February 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. 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

2. 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

3. 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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• FIRE1 System
FIRE1 System

Locations

Country	Name	City	State
United States	Austin Heart Central at the Heart Hospital of Austin	Austin	Texas
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Columbia University Irving Medical Center/ New York Presbyterian Hospital	New York	New York
United States	Rochester General Hospital	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Foundry Innovation & Research 1, Limited (FIRE1)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint - Procedural success	Procedural success defined as Sensor deployment at the intended site without procedural related SAEs	30 days
Primary	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	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	Exploratory Safety Outcome	Summary of all device / system related adverse events (AEs)	24 months
Secondary	Exploratory Safety Outcome	Summary of all device / system related complications	24 months