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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: NORM™ System

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 30 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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medica Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/ New York Presbyterian hospital
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart Central at the Heart Hospital of Austin

Participation Criteria

Eligibility Criteria

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

Description

Main Inclusion Criteria

• Adults 18 years of age 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/HFSA guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidenced by meeting either 2a, 2b, OR 2c criterion below:

  1. NYHA functional class III: with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF and NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL). For patients presenting with atrial fibrillation NT-proBNP ≥900 pg/mL (or BNP ≥300 pg/mL).

     OR

  2. NYHA functional class III: NT-proBNP ≥1000 pg/mL (or BNP ≥300pg/mL). For patients presenting with atrial fibrillation NT-proBNP≥1,600 pg/mL (or BNP ≥500 pg/mL).

     OR

  3. NYHA functional class II: with documented HF decompensation within the previous 12 months resulting in a primary HFhospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL (or BNP ≥300 pg/mL). For those patients presenting with atrial fibrillation NT-proBNP ≥1,600 pg/mL (or BNP ≥500 pg/mL).
• Patients must also be on a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the 2 weeks prior to screening.
• IVC diameter within the landing zone of between 14mm and 28mm.
• Minimum IVC landing zone length of 60mm.
• Patient has sufficient Cellular and/ or Wi-Fi Internet coverage at home.
• Provide informed consent for participation in the clinical investigation and be willing and able to comply with the required daily system readings, care plan instructions, and clinical follow-up visits according to the specified schedule.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NORM™ System	Device: NORM™ System; NORM™ System

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 NORM™ 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

Collaborators and Investigators

• Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)
• Investigators: Study Director: Carolyn Borme, Director Clinical US

Publications and helpful links

General Publications

• Uriel N, Mehra MR, Greene BR, Bhatt K, Kahwash R, Feitell S, Sayer G, Martyn T, Borme C, Sweeney F, Testani J, Fudim M. Physician-Directed Patient Self-Management Using an Implantable IVC Congestion Sensor: Insights From FUTURE-HFII. JACC Heart Fail. 2026 Mar 3:103011. doi: 10.1016/j.jchf.2026.103011. Online ahead of print.
• Uriel N, Bhatt K, Kahwash R, McMinn TR, Patel MR, Lilly S, Britton JR, Corcoran L, Greene BR, Kealy RM, Kent A, Sheridan WS, Kirtane AJ, Sethi SS, Depta JP, Feitell SC, Sayer G, Fudim M. Safety and Feasibility of an Implanted Inferior Vena Cava Sensor for Accurate Volume Assessment: FUTURE-HF2 Trial. J Card Fail. 2025 Feb;31(2):369-376. doi: 10.1016/j.cardfail.2024.09.003. Epub 2024 Sep 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Disease
• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases
• Other Study ID Numbers: TF03-CID02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No