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

• ClinicalTrials.gov Identifier: NCT05763407
• Recruitment Status: Active, not recruiting
• First Posted: March 10, 2023
• Last Update Posted: March 8, 2024
• Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
• Information provided by (Responsible Party): Foundry Innovation & Research 1, Limited (FIRE1)

Study Description

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

Condition or disease	Intervention/treatment	Phase
Heart Failure	Device: FIRE1 System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Early Feasibility Study of the FIRE1™ System in Heart Failure Patients (FUTURE-HF2)
• Actual Study Start Date: June 19, 2023
• Estimated Primary Completion Date: May 2024
• Estimated Study Completion Date: February 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: FIRE1 System; FIRE1 System	Device: FIRE1 System; FIRE1 System

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Exploratory Safety Outcome [ Time Frame: 24 months ]
   Summary of all device / system related adverse events (AEs)
2. Exploratory Safety Outcome [ Time Frame: 24 months ]
   Summary of all device / system related complications

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

  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.

Contacts and Locations

Locations

United States, New York

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, United States, 10032

Rochester General Hospital

Rochester, New York, United States, 14621

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

United States, Ohio

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

United States, Texas

Austin Heart Central at the Heart Hospital of Austin

Austin, Texas, United States, 78756

Sponsors and Collaborators

Foundry Innovation & Research 1, Limited (FIRE1)

More Information

• Responsible Party: Foundry Innovation & Research 1, Limited (FIRE1)
• ClinicalTrials.gov Identifier: NCT05763407
• Other Study ID Numbers: TF03-CID02
• First Posted: March 10, 2023
• Last Update Posted: March 8, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Foundry Innovation & Research 1, Limited (FIRE1):

Cardiovascular Disease

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases