Early Feasibility Study of the NORM™ System in Heart Failure Patients
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
NORM™ System
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
Primary Safety Endpoint - Procedural success
Procedural success defined as Sensor deployment at the intended site without procedural related SAEs
Time frame: 30 days
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
Time frame: 3 months
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
Time frame: 3 months
Exploratory Safety Outcome
Summary of all device / system related adverse events (AEs)
Time frame: 24 months
Exploratory Safety Outcome
Summary of all device / system related complications
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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