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NYHA Class III Heart Failure / Heart Failure / NYHA Class Ii Heart Failure · Interventional Study
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered but active, multi-center randomized controlled trial of the FIRE1 NORM™ IVC sensor system in NYHA Class II/III heart failure patients. The trial plans to enroll 800 participants and compare the device plus guided HF management against standard care on a composite of cardiovascular death and worsening HF events (5-year primary efficacy endpoint) and freedom from composite safety endpoints (12 months). No results are yet available in this registry record.
Interventional, Randomized, Factorial, Open label, Prevention purpose. Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure; age from 18 Years. Intervention: Intervention. Compared with: Control — No Intervention. n = 800. 8 sites: United States.
This is a registered but active, multi-center randomized controlled trial of the FIRE1 NORM™ IVC sensor system in NYHA Class II/III heart failure patients. The trial plans to enroll 800 participants and compare the device plus guided HF management against standard care on a composite of cardiovascular death and worsening HF events (5-year primary efficacy endpoint) and freedom from composite safety endpoints (12 months). No results are yet available in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned interventional study with no results posted; it reports design and enrollment targets only, not outcomes.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07574593). This is a study registration, not published results. Lead sponsor: Foundry Innovation & Research 1, Limited (FIRE1). Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Heart Failure, NYHA Class III Heart Failure, NYHA Class II Heart Failure. Interventions: DEVICE: IVC Sensor. Primary outcome measures: The primary efficacy endpoint is a composite total number of CV death and worsening HF events, as adjudicated by an independent CEC. , Up to 5 years; The primary safety endpoint is freedom from a composite of clinical endpoints. , 12 months. Brief 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.