Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Device: FIRE1 System

• Registration Number: NCT05763407
• Lead Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)

Brief Summary

Early Feasibility Study of the NORM™ System in Heart Failure Patients

Detailed Description

Eligible patients who have HF and were hospitalised/treated for an episode of worsening HF within the last 12 months and/or elevated NTproBNP levels.

This non-randomised trial will enroll up to 25 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 Timeline

• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Study Start: 2023-06-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-04
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FIRE1 System	FIRE1 System	FIRE1 System

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Freedom from Sensor Complications	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
Primary Safety Endpoint - Procedural success	30 days	Procedural success defined as Sensor deployment at the intended site without procedural related SAEs
Primary Effectiveness Endpoint - Device Performance	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

Name	Time	Method
Exploratory Safety Outcome	24 months	Summary of all device / system related complications

Trial Locations

Locations (5)

Columbia University Irving Medical Center/ New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Austin Heart Central at the Heart Hospital of Austin; 🇺🇸 Austin, Texas, United States