Testing a nerve-stimulating device to lower resistant high blood pressure

Plain-English translation of NCT06518915 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated June 2026 · How we translate trials

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?

This trial is testing a device called the Baroloop, which is implanted in the neck and works by gently stimulating a nerve to help lower blood pressure. The study wants to find out if the device is safe and whether it actually helps people whose high blood pressure hasn't improved enough with standard medications. Researchers will follow participants for two years to see how well the treatment works.

Some people with high blood pressure continue to have dangerously elevated readings even when taking multiple medications. This trial exists to see if this new device approach could offer another treatment option for people whose blood pressure is not controlled by drugs alone.

Do you qualify?

You likely qualify if…

you are 18 years or older
your systolic blood pressure stays at 140 mm Hg or higher despite taking three different blood pressure medications
you have been stable on three blood pressure medications for at least four weeks
you are willing to attend clinic visits at regular intervals for two years
you have normal or near-normal kidney function

You likely don't qualify if…

you have had a stroke or mini-stroke in the last six months
you have a pacemaker or implantable defibrillator already in place
you have significant narrowing or disease of the carotid arteries in your neck
you have had prior surgery or radiation in the neck area
you are currently taking blood thinners (other than aspirin alone) or have bleeding disorders

What participation looks like

If you join this trial, you will have surgery to implant the Baroloop device in your neck. After that, you will visit the clinic at regular intervals—at two weeks, three months, six months, one year, eighteen months, and two years—so doctors can adjust the device settings and check how well it is working. During these visits, your blood pressure will be measured and you will answer questions about how you are feeling and your quality of life.

AI-generated summary from trial data · Jun 5, 2026 · Not medical advice

Trial locations(4 sites)

Germany

Clemenshospital Münster, Münster, North Rhine-Westphalia

Marienhaus Klinikum Mainz, Mainz, Rhineland-Westphalia

Städtisches Klinikum Dresden, Dresden, Saxony

Netherlands

UMC Utrecht, Utrecht, Utrecht