NORM-HF Pivotal Study
Public ClinicalTrials.gov record NCT07574593. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
NORM-HF (NORM-guided Congestion Management in Heart Failure) Pivotal Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT07574593
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 800 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 29, 2026 (Actual)
- Primary completion
- Aug 2029 (Estimated)
- Completion
- Dec 2033 (Estimated)
- Last update posted
- Oct 16, 2026
2026 – 2033
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiovascular Institute of San Diego | Chula Vista | California | 91911 | Recruiting |
| UC Davis | Sacramento | California | 95817 | Recruiting |
| University of Florida Health - Jacksonville | Jacksonville | Florida | 32209 | Recruiting |
| Tampa General Hospital | Tampa | Florida | 33606 | Recruiting |
| Baycare Health System | Tampa | Florida | 33607 | Recruiting |
| Cardiovascular Institute of the South | Baton Rouge | Louisiana | 70809 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Recruiting |
| NYU Langone | New York | New York | 10016 | Not yet recruiting |
| Columbia University Irving Medical Center/ New York Presbyterian Hospital | New York | New York | 10032 | Not yet recruiting |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | Recruiting |
| Christ Hospital Lindner | Cincinnati | Ohio | 45219 | Recruiting |
| Ohio State University Hospital | Colombus | Ohio | 43210 | Recruiting |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | Recruiting |
| Saint Francis Health System | Tulsa | Oklahoma | 74136 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Prisma Health - Midlands | Columbia | South Carolina | 29203 | Recruiting |
| Prisma Health - Upstate | Greenville | South Carolina | 29605 | Recruiting |
| North Central Heart - Avera Hospital | Sioux Falls | South Dakota | 57108 | Recruiting |
| Baylor Scott & White - Dallas | Dallas | Texas | 75246 | Recruiting |
| Baylor Scott & White - Plano | Plano | Texas | 75093 | Recruiting |
| Baylor Scott & White - Round Rock | Round Rock | Texas | 78665 | Recruiting |
| Baylor Scott & White - Temple | Temple | Texas | 76508 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07574593, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07574593 live on ClinicalTrials.gov.