Recruiting

Testing a sensor system to better manage heart failure symptoms

Plain-English translation of NCT07574593 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Read our Heart Failure research guide →

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

The NORM-HF trial is testing a device called the FIRE1 NORM System—a small implanted sensor that helps doctors and patients monitor heart failure more closely. The sensor works together with your regular medications and doctor visits to catch signs of worsening heart failure early. Researchers believe this approach may help prevent hospitalizations and serious complications better than standard care alone.

Heart failure can worsen suddenly, sometimes leading to emergency hospital visits that might be preventable. This trial exists to see whether continuous monitoring with the new sensor system—combined with early treatment adjustments—can catch problems before they become dangerous.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have been diagnosed with heart failure for at least 90 days and are already on the best medicines your doctor recommends
you have moderate heart failure symptoms (NYHA Class II or III) with recent worsening that required hospitalization, urgent care, or IV medication within the past year
you are currently taking a loop diuretic (water pill) at a dose of at least 40 mg furosemide or equivalent daily
you have stable internet or cellular service at home and can access the internet by phone or computer

You likely don't qualify if…

you have very severe heart failure (NYHA Class IV) or are currently on IV medications to support your heart function
you are already on a waiting list for a heart transplant or mechanical heart support device, or expected to need one within 6 months
you have severe kidney disease with an estimated glomerular filtration rate below 25 or are on dialysis
you have an abdominal circumference greater than 143 cm (56 inches), which may make the sensor placement difficult
you have severe valve disease on the right side of your heart or a mechanical valve on the right side

What participation looks like

If you join this trial, you will be randomly assigned to one of two groups. One group will have the NORM sensor implanted (a quick procedure similar to placing a pacemaker) and will use it along with regular medications and doctor visits. The other group will continue standard care with their regular doctor visits and medications. Both groups will have regular check-ins with the research team to monitor your heart failure over time. You'll need to be able to attend follow-up visits and, if in the sensor group, use a phone or computer app to share information with your doctor.

AI-generated summary from trial data · Jun 11, 2026 · Not medical advice

Trial locations(2 sites)

United States

Saint Francis Health System, Tulsa, Oklahoma

North Central Heart - Avera Hospital, Sioux Falls, South Dakota