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NCT07574593 · ClinicalTrials.gov registry record · NA
NORM-HF Pivotal Study
A NA study, sponsored by Foundry Innovation & Research 1, Limited (FIRE1).
- Recruiting
- Registry status
- NA
- Development phase
- 800
- Enrollment target
NCT07574593 is a NA study that is actively recruiting participants, run by Foundry Innovation & Research 1, Limited (FIRE1). The registered enrollment target is 800 participants.
The verdict
NCT07574593, a NA study, is actively recruiting participants, sponsored by Foundry Innovation & Research 1, Limited (FIRE1).
- RECRUITING
- Registry status
- NA
- Development phase
- 800 participants
- Enrollment target
Study 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).
Interventions
- DEVICE IVC Sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2026-05-29 |
| Est. Completion | 2033-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07574593
The ClinicalTrials.gov registry entry for NCT07574593 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Foundry Innovation & Research 1, Limited (FIRE1), which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IVC Sensor is the first listed.
NCT07574593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07574593 about?
NCT07574593 is a clinical study titled "NORM-HF Pivotal Study". 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...
What is the current status of trial NCT07574593?
This trial is currently recruiting. It is a NA study. The enrollment target is 800 participants. The study started on 2026-05-29. Estimated completion is 2033-12.
What interventions are being tested in trial NCT07574593?
The interventions under investigation include: IVC Sensor (DEVICE).
Who is sponsoring clinical trial NCT07574593?
This trial is sponsored by Foundry Innovation & Research 1, Limited (FIRE1), which has 2 total clinical trials registered on ClinicalTrials.gov.
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