BayCare Health System is expanding its role in clinical research through its participation in the NORM-HF pivotal trial, an international study evaluating a new physiologically guided approach to heart failure management.
Interventional cardiologists Firas Almahasneh and Alok Singh performed the first implant of the investigational Norm™ System at BayCare’s St. Joseph’s Hospital in Tampa on Sept. 30. The study is led by Nirav Raval, MD, medical director of BayCare’s Heart and Vascular Institute, with Eugene DePasquale, MD, a heart failure and transplant specialist, serving as sub-investigator.
Sponsored by FIRE1, the trial will evaluate whether the Norm™ System can help patients and physicians identify early signs of fluid buildup, called congestion, before symptoms become severe enough to require urgent care or hospitalization.
The system uses a small, implanted sensor placed in the inferior vena cava, a large vein that carries blood back to the heart. Patients take daily readings from home through a connected app that follows a physician-directed care plan.
BayCare’s participation reflects its continued investment in research and its commitment to bringing promising medical advances to the communities it serves. Through clinical trials like NORM-HF, BayCare is helping connect patients in West Central Florida with innovative care close to home.
“BayCare is proud to participate in research that may change how we care for patients with heart failure,” said Dr. Raval. “This technology brings together physiologic data, patient self-management and physician oversight, giving patients a more active role in their care while helping care teams respond earlier and more effectively.”
The trial is expected to enroll about 800 people with a New York Heart Association Functional Classification of Class II or III heart failure who are at increased risk of worsening symptoms. Researchers will compare patients using the Norm System with patients receiving usual heart failure care.
The study will assess whether earlier warning signs, combined with physician-directed action plans can help patients and care teams identify concerning changes before they become a medical emergency.
As the largest academic health system in West Central Florida, BayCare participates in clinical trials like NORM-HF to help advance medical research and provide patients access to investigational therapies and technologies.
The Norm System is investigational and is not approved for commercial use in any geography.
Learn more: BayCare’s Heart and Vascular Institute
