NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
Foundry Innovation & Research 1, Limited (FIRE1)
Summary
This is an international, multi-center, prospective, randomized, open-label blinded endpoint study designed to demonstrate that use of the FIRE1 NORM™ System in the management of New York Heart Association Class II/III HF patients is superior for reducing the combined endpoint of worsening HF events and cardiovascular mortality compared to standard of care treatment. Patients will be randomized in a 1:1 ratio to receive either NORM™ System and guided heart failure management (intervention group) or usual standard of care with guided heart failure management (control group).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: 1. Adults 18 years of age or older. 2. Provide informed consent for participation in the clinical study and be willing and able to comply with the required assessments, treatment instructions, and clinical follow-up visits according to the specified schedule. 3. Patients meeting diagnostic criteria for HF 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 or ESC HF guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidence…
Interventions
- DeviceIVC Sensor
Patients will be implanted with an inferior vena cava sensor
Locations (2)
- Saint Francis Health SystemTulsa, Oklahoma
- North Central Heart - Avera HospitalSioux Falls, South Dakota