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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

‣ OR

⁃ 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

⁃ 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.

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Columbia University Irving Medical Center/ New York Presbyterian Hospital
RECRUITING
New York
Rochester General Hospital
RECRUITING
Rochester
Ohio
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Texas
Austin Heart Central at the Heart Hospital of Austin
RECRUITING
Austin
Contact Information
Primary
Carolyn Borme
clinical@fire1foundry.com
+35319089012
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2027-06
Participants
Target number of participants: 25
Treatments
Experimental: NORM™ System
NORM™ System
Related Therapeutic Areas
Sponsors
Leads: Foundry Innovation & Research 1, Limited (FIRE1)

This content was sourced from clinicaltrials.gov

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