Using the NORM™ System for Heart Failure Patients

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

This study is testing the NORM™ System to see if it can help heart failure patients who have had worsening symptoms in the past year feel better and stay safe over two years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Foundry Innovation & Research 1, Limited (FIRE1) (Industry-sponsored)
• Locations: 6 sites (New York, New York and 5 other locations)
• Trial ID: NCT05763407 on ClinicalTrials.gov

What this trial studies

This study evaluates the NORM™ System in patients with heart failure who have experienced worsening symptoms within the last year. It aims to enroll up to 25 patients who meet specific criteria related to heart failure diagnosis and treatment. The trial will assess safety and technical endpoints over a 3-month period, with participants monitored for a total of 24 months. The study focuses on patients who are on optimal medical therapy and have elevated NT-proBNP levels.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented heart failure diagnosis and recent hospitalization or treatment for worsening heart failure.

Not a fit: Patients who do not have heart failure or those who have not been hospitalized for heart failure in the past year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for managing heart failure symptoms and improving patient outcomes.

How similar studies have performed: While this approach is novel, similar studies have shown promise in managing heart failure with innovative systems.

Eligibility criteria

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.

Where this trial is running

New York, New York and 5 other locations

• Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States (Recruiting)
• Rochester General Hospital — Rochester, New York, United States (Recruiting)
• Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• Austin Heart Central at the Heart Hospital of Austin — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Carolyn Borme

Conditions Heart Failure; Cardiovascular Disease