NORM-HF Pivotal Study
NCT07574593
This study is recruiting at 22 US sites in 13 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Heart Failure
- NYHA Class III Heart Failure
- NYHA Class II Heart Failure
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Foundry Innovation & Research 1, Limited (FIRE1)
- Last updated on ClinicalTrials.gov
- October 16, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Cardiovascular Institute of San Diego · Chula Vista, CA
- UC Davis · Sacramento, CA
Florida · 3
- University of Florida Health - Jacksonville · Jacksonville, FL
- Baycare Health System · Tampa, FL
- Tampa General Hospital · Tampa, FL
Louisiana · 1
- Cardiovascular Institute of the South · Baton Rouge, LA
Massachusetts · 1
- Massachusetts General Hospital · Boston, MA
Missouri · 1
- Saint Luke's Hospital of Kansas City · Kansas City, MO
Nebraska · 1
- University of Nebraska Medical Center · Omaha, NE
North Carolina · 1
- University of North Carolina · Chapel Hill, NC
Ohio · 2
- Christ Hospital Lindner · Cincinnati, OH
- ProMedica Toledo Hospital · Toledo, OH
Oklahoma · 1
- Saint Francis Health System · Tulsa, OK
Pennsylvania · 2
- Thomas Jefferson University Hospital · Philadelphia, PA
- University of Pennsylvania · Philadelphia, PA
South Carolina · 2
- Prisma Health - Midlands · Columbia, SC
- Prisma Health - Upstate · Greenville, SC
South Dakota · 1
- North Central Heart - Avera Hospital · Sioux Falls, SD
Texas · 4
- Baylor Scott & White - Dallas · Dallas, TX
- Baylor Scott & White - Plano · Plano, TX
- Baylor Scott & White - Round Rock · Round Rock, TX
- Baylor Scott & White - Temple · Temple, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.