NORM-HF Pivotal Study
Sponsor: Foundry Innovation & Research 1, Limited (FIRE1) • ClinicalTrials.gov ID: NCT07574593
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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
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IVC Sensor
(Device)
Patients will be implanted with an inferior vena cava sensor
Eligibility criteria
Conditions
Locations
- Cardiovascular Institute of San Diego — Chula Vista, California, United States
- UC Davis — Sacramento, California, United States
- University of Florida Health - Jacksonville — Jacksonville, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Baycare Health System — Tampa, Florida, United States
- Cardiovascular Institute of the South — Baton Rouge, Louisiana, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- NYU Langone — New York, New York, United States
- Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- Christ Hospital Lindner — Cincinnati, Ohio, United States
- Ohio State University Hospital — Colombus, Ohio, United States
- ProMedica Toledo Hospital — Toledo, Ohio, United States
- Saint Francis Health System — Tulsa, Oklahoma, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Prisma Health - Midlands — Columbia, South Carolina, United States
- Prisma Health - Upstate — Greenville, South Carolina, United States
- North Central Heart - Avera Hospital — Sioux Falls, South Dakota, United States
- Baylor Scott & White - Dallas — Dallas, Texas, United States
- Baylor Scott & White - Plano — Plano, Texas, United States
- Baylor Scott & White - Round Rock — Round Rock, Texas, United States
- Baylor Scott & White - Temple — Temple, Texas, United States
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Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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