NORM-HF Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFoundry Innovation & Research 1, Limited (FIRE1)
About this trial
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 criteria
Qualifiers
Adults 18 years of age or older.
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.
NYHA functional class II 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 ≥1000 pg/mL. For those patients presenting with atrial fibrillation or flutter, NT-proBNP ≥1,600 pg/mL.
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. For patients presenting with atrial fibrillation or flutter, NT-pro BNP ≥900 pg/mL.
Disqualifiers
Persistent NYHA functional class IV HF (ACC/AHA/ESC).
Current treatment with intravenous vasopressors or inotropes.
Received, or are likely to receive in the next 6 months, an advanced therapy (e.g., mechanical circulatory support or cardiac transplant or previously listed for transplant).
Receiving end of life HF care.
Trial design
Treatments tested in this trial
- IVC Sensor
Treatment groups
800 Participants
are divided into 2 treatment groupsSponsors and collaborators
Foundry Innovation & Research 1, Limited (FIRE1)
Lead sponsor
NAMSA
Collaborator
Baim Institute for Clinical Research
Collaborator
Source ClinicalTrials.gov