Tiny implant beams heart data from inside the body
NCT ID NCT05763407
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This early study tests a new device called the NORM™ system in 25 adults with heart failure. The device is placed inside a large vein near the heart to send health information to doctors. The goal is to see if the implant is safe and can reliably transmit data, which may help manage the condition long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Main Inclusion Criteria * Adults 18 years of age or older. * Patients meeting diagnostic criteria for heart failure diagnosis for greater than 90 days and are on optimally tolerated medical therapy for at least 30 days, as recommended according to current AHA/ACC/HFSA guidelines with any intolerance or contraindications documented, regardless of ejection fraction, as evidenced by meeting either 2a, 2b, OR 2c criterion below: 1. NYHA functional class III: with documented HF decompensation within the previous 12 months resulting in a primary HF hospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF and NT-proBNP ≥600 pg/mL (or BNP ≥200 pg/mL). For patients presenting with atrial fibrillation NT-proBNP ≥900 pg/mL (or BNP ≥300 pg/mL). OR 2. NYHA functional class III: NT-proBNP ≥1000 pg/mL (or BNP ≥300pg/mL). For patients presenting with atrial fibrillation NT-proBNP≥1,600 pg/mL (or BNP ≥500 pg/mL). OR 3. NYHA functional class II: with documented HF decompensation within the previous 12 months resulting in a primary HFhospitalization, HF treatment in a hospital day-care setting or unscheduled visit to a healthcare provider for administration of an intravenous diuretic to treat HF AND NT-proBNP ≥1000 pg/mL (or BNP ≥300 pg/mL). For those patients presenting with atrial fibrillation NT-proBNP ≥1,600 pg/mL (or BNP ≥500 pg/mL). * Patients must also be on a daily dose of loop diuretic of 40mg or more furosemide, or equivalent, for the 2 weeks prior to screening. * IVC diameter within the landing zone of between 14mm and 28mm. * Minimum IVC landing zone length of 60mm. * Patient has sufficient Cellular and/ or Wi-Fi Internet coverage at home. * Provide informed consent for participation in the clinical investigation and be willing and able to comply with the required daily system readings, care plan instructions, and clinical follow-up visits according to the specified schedule. Main Exclusion Criteria: * Significant comorbidity that, in the investigator's opinion, would results in the patient being unable to safely undergo the procedure or participate in the clinical investigation. * Patients with an estimated Glomerular Filtration Rate (eGFR) \< 25 ml/min/1.73m2 * Patients with an in vivo IVC filter, abnormal IVC or femoral venous anatomy or known congenital malformation or absence of IVC or occlusive or free-floating thrombus in the IVC. * Patients who have severe right sided valvular disease or a right sided mechanical valve. * Patients with a cardiac resynchronization therapy device implanted ≤ 3 months to prior to screening. * Patients who have undergone invasive cardiac surgery in the 3 months prior to screening. * Patients who have undergone percutaneous valve / structural heart intervention in in the 3 months prior to screening. * Patients who have received heart transplant or a ventricular assist device or planned for advanced therapies within the next year. * Patients with conditions associated with occlusion of the IVC, iliac or common femoral veins.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Heart Central at the Heart Hospital of Austin
Austin, Texas, 78756, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Columbia University Irving Medical Center/ New York Presbyterian Hospital
New York, New York, 10032, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Prisma Health
Greenville, South Carolina, 29605, United States
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Rochester General Hospital
Rochester, New York, 14621, United States
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The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
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University of Minnesota Medica Center
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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