Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
NCT ID: NCT05763407
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2023-06-19
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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NORM™ System
NORM™ System
NORM™ System
NORM™ System
Interventions
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NORM™ System
NORM™ System
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Foundry Innovation & Research 1, Limited (FIRE1)
INDUSTRY
Responsible Party
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Principal Investigators
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Carolyn Borme
Role: STUDY_DIRECTOR
Director Clinical US
Locations
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University of Minnesota Medica Center
Minneapolis, Minnesota, United States
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
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
Austin Heart Central at the Heart Hospital of Austin
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Tamas Alexy, MD
Role: primary
Gabriel Sayer, MD
Role: primary
Scott Feitell, DO
Role: primary
Marat Fudim, MD
Role: primary
Trejeeve Martyn, MD
Role: primary
Rami Kahwash, MD
Role: primary
Jason Guichard
Role: primary
Kunjan Bhatt, MD
Role: primary
Other Identifiers
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TF03-CID02
Identifier Type: -
Identifier Source: org_study_id