Heart Failure
Conditions
Keywords
Cardiovascular Disease
Brief summary
Early Feasibility Study of the NORM™ System in Heart Failure Patients
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.
Interventions
DEVICENORM™ System
NORM™ System
Sponsors
Foundry Innovation & Research 1, Limited (FIRE1)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Procedural success | 30 days | Procedural success defined as Sensor deployment at the intended site without procedural related SAEs |
| Primary Safety Endpoint - Freedom from Sensor Complications | 3 months | 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 |
| Primary Effectiveness Endpoint - Device Performance | 3 months | Device performance defined as an assessment of the ability of the NORM™ System to successfully transmit collected data to a secure database |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Safety Outcome | 24 months | Summary of all device / system related adverse events (AEs) |
Countries
United States
Contacts
STUDY_DIRECTORCarolyn Borme
Director Clinical US
Outcome results
None listed