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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: Recruiting NA study, sponsored by Foundry Innovation & Research 1, Limited (FIRE1).
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07574593 shows while recruiting
NCT07574593 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which IVC Sensor is the first listed.
NCT07574593 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07574593's enrollment target sits among peer trials
800 135th of 2000 higher than 1,861 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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