International, randomized study to evaluate whether daily inferior vena cava (IVC) monitoring and physician-directed patient self-management can reduce worsening heart failure events and cardiovascular mortality

DUBLIN, Sept. 30, 2026 /PRNewswire/ — FIRE1 announced today the enrollment of the first patients in the NORM-HF pivotal trial, an international, multicenter, randomized study evaluating a new physiologically guided approach to heart failure management. The trial will assess whether the investigational Norm™ System can detect worsening congestion early through daily monitoring of inferior vena cava (IVC) physiology and enable patients to take physician-prespecified treatment actions through a connected patient app. This approach, designed to combine earlier physiologic insight with physician-directed patient self-management, will be compared with usual heart failure care without the investigational Norm System. Approximately 800 patients will be randomized. The first patient was randomized at the Cardiovascular Institute of San Diego under the leadership of Burhan Mohamedali, MD, and the first Norm System was implanted at BayCare Hospital in Tampa, Florida, where Principal Investigator Nirav Raval, MD, and Sub-Investigator Eugene DePasquale, MD, are leading study activities.

Heart failure, which affects roughly 6.7 million patients in the U.S. alone, remains one of the largest and most costly challenges in healthcare, contributing to recurrent hospitalizations, impairing quality of life, and posing a substantial burden for patients, caregivers, clinicians, and health systems.

Monitoring of patients with heart failure is used to detect the development or worsening of fluid retention, known as congestion, which may indicate that the heart is no longer able to accommodate the body’s circulatory demands effectively. A central goal of patient monitoring is to identify worsening congestion early, before clinical deterioration leads to urgent care visits, hospitalization, or death. The Norm System was designed to address this unmet need for earlier detection through a minimally invasive implanted sensor positioned in the inferior vena cava (IVC), where it measures dynamic changes in IVC size and collapsibility that reflect evolving volume status and venous congestion physiology.

Patients use the Norm system at home to take daily readings that generate a patient-specific Norm Congestion Score, which is intended to help patients and clinicians recognize changes from the patient’s physiologic baseline. Under a predefined, physician-directed care plan programmed into the patient app, patients can self-manage their condition following the app’s prompts for protocol-based therapy adjustments, all while the clinical team remains connected to the patient’s clinical status.

The NORM-HF pivotal trial will test whether this approach can improve clinical outcomes in patients with New York Heart Association Class II or III heart failure who are at increased risk of decompensation. The primary endpoint is a composite of worsening heart failure events and cardiovascular mortality.

“NORM-HF is not simply evaluating a new sensor–it is evaluating a potentially transformative model of heart failure care that will enable the patient to be actively engaged in their disease management,” said Conor Hanley, Chief Executive Officer of FIRE1. “Our goal is to determine whether physiologically guided, physician-directed self-management can help patients and clinicians identify congestion earlier, act sooner, and support a more scalable approach to heart failure care.”

Existing implanted remote-monitoring approaches require substantial ongoing clinician review, interpretation, and intervention. These workflow demands, together with procedural and adoption barriers, have limited the use of implanted physiologic monitoring relative to the large number of heart failure patients who may be eligible.

NORM-HF is evaluating whether a more scalable care model can improve outcomes while preserving clinician oversight, a model that combines daily IVC-based physiologic monitoring, physician-defined treatment algorithms, and patient-executed, physician-prespecified action plans. By moving beyond symptom-based management alone and toward daily physiologic assessment, NORM-HF aims to usher in a novel paradigm of proactive and personalized heart failure care to lessen the burden of the disease.

“The NORM-HF trial will rigorously test whether information from the device – which reflects a very early signal of congestion before heart failure symptoms develop – can help guide management to reduce heart failure hospitalizations and improve outcomes,” said James Udelson MD, Chief of Cardiology at Tufts Medical Center in Boston as well as Principal Investigator and Steering Committee Chair for the NORM-HF trial. “A very novel and exciting part of this trial is that patients themselves will be empowered to make changes in their everyday drug regimen in response to the NORM signals, in contrast to prior trials where almost all decisions were made by a medical team.”

The Norm System is investigational and is not approved for commercial use in any geography.

About FIRE1

Headquartered in Dublin, Ireland, FIRE1 is a connected medical device solutions company dedicated to improving outcomes for individuals suffering from chronic diseases. Its mission is to empower millions of people with heart failure to regain their normal lives. The experienced FIRE1 team collaborates with world-leading researchers, clinicians, patients, and payors to alleviate the burden of heart failure.

For more information, visit www.fire1foundry.com.

Media Contact: 
Jeff Christensen
SignalWest Public Relations
Phone: (831) 566-0275
Jeff@SignalWestPR.com

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SOURCE FIRE1