RecruitingNot ApplicableNCT07574593

NORM-HF Pivotal Study

NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study

Sponsor

Foundry Innovation & Research 1, Limited (FIRE1)

Enrollment

800 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

Heart Failure NYHA Class III Heart Failure NYHA Class II Heart Failure

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called IVC Sensor for people with heart failure, nyha class ii heart failure, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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