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RECRUITING
NCT07574593
NA

NORM-HF Pivotal Study

Sponsor: Foundry Innovation & Research 1, Limited (FIRE1)

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2026-05-29

Completion Date

2033-12

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

DEVICE

IVC Sensor

Patients will be implanted with an inferior vena cava sensor

Locations (2)

Saint Francis Health System

Tulsa, Oklahoma, United States

North Central Heart - Avera Hospital

Sioux Falls, South Dakota, United States