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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

2026-06-24

Healthy Volunteers

No

Interventions

DEVICE

IVC Sensor

Patients will be implanted with an inferior vena cava sensor

Locations (3)

Cardiovascular Institute of San Diego

Chula Vista, California, United States

Saint Francis Health System

Tulsa, Oklahoma, United States

North Central Heart - Avera Hospital

Sioux Falls, South Dakota, United States