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

NCT05763407 | Active Not Recruiting DMC FDA Device

• 1 other identifier: TF03-CID02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Heart Failure

Keywords

Cardiovascular Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Exploratory Safety Outcome

  24 months

• Exploratory Safety Outcome

  24 months

Study Arms (1)

NORM™ System

EXPERIMENTAL

NORM™ System

Device: NORM™ System

Interventions

NORM™ System DEVICE

NORM™ System

NORM™ System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundry Innovation & Research 1, Limited (FIRE1): lead

Study Sites (8)

University of Minnesota Medica Center

Minneapolis, Minnesota, 55455, United States

Location

Columbia University Irving Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Austin Heart Central at the Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

Related Publications (2)

• 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.

  PMID: 41860506 DERIVED

• 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.

  PMID: 39349159 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Carolyn Borme

  Director Clinical US

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)