Plain-English translation of NCT05428631 on ClinicalTrials.gov ↗ · Source last updated ·
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing the CARDIOMEMS™ HF device, a tiny wireless sensor that is placed inside the blood vessel leading to your lungs during a minimally invasive procedure. The sensor continuously measures pressure in your heart's blood vessels and sends this information to your doctor, allowing them to adjust your medications earlier and potentially prevent you from needing to go to the hospital. The trial is specifically for patients who have both serious heart failure and severe kidney disease, a combination that makes treatment very challenging.
Most heart failure patients with severe kidney disease were excluded from earlier studies of this device, so doctors don't have good data on whether the treatment works safely and effectively for them. This trial aims to fill that gap and see if continuous heart monitoring can help prevent hospitalizations and improve kidney function in this high-risk group.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will undergo a right heart catheterization procedure, during which doctors will insert a small tube into a blood vessel and place the wireless sensor in your pulmonary artery — this usually takes 1–2 hours and is done under sedation. After implantation, you will take blood-thinning medications for one month to prevent clots around the device. You will then have regular follow-up visits where the sensor will transmit heart pressure readings to your care team, who will use this information to adjust your medications and manage your condition. The study involves approximately 10 patients at a hospital in France and will closely monitor your safety and how well your heart and kidneys respond to this type of monitoring.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
France