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Heart FailureNCT05763407

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

A study testing NORM™ System in people with Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Early Feasibility Study of the NORM™ System in Heart Failure Patients Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
NORM™ System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
8 sitesUnited States
Study dates
19 Jun 2023to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Austin Heart Central at the Heart Hospital of Austin

    Austin, Texas, 78756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Prisma Health

    Greenville, South Carolina, 29605

  • University of Minnesota Medica Center

    Minneapolis, Minnesota, 55455

  • Columbia University Irving Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

  • Rochester General Hospital

    Rochester, New York, 14621

Other trials in United States

About this study

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

Read the 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.

Conditions
Heart Failure
Being tested
NORM™ System
Keywords
Cardiovascular Disease
Medical subject headings
Heart Failure, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NORM™ SystemDevice

    NORM™ System

Study groups in NCT05763407
Study groupRoleWhat they receive
NORM™ SystemExperimentalNORM™ System
Receives: Device: NORM™ System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint - Procedural success

    Procedural success defined as Sensor deployment at the intended site without procedural related SAEs

    Measured: 30 days

  2. 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

    Measured: 3 months

  3. 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

    Measured: 3 months

Secondary outcomes (2)

  1. Exploratory Safety Outcome

    Summary of all device / system related adverse events (AEs)

    Measured: 24 months

  2. Exploratory Safety Outcome

    Summary of all device / system related complications

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start19 Jun 2023
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763407
Sponsor's protocol ID
TF03-CID02
Status last verified
Aug 2026
First submitted
28 Feb 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 41860506

  • 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.

    PubMed 39349159

Questions about this trial

What is this clinical trial studying?

A study testing NORM™ System in people with Heart Failure, run by Foundry Innovation & Research 1, Limited (FIRE1) at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint - Procedural success (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05763407, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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