The goal of this clinical trial is to learn weather the baroloop system is safe and works to treat hypertension in adults that do not respond sufficiently to medication. The main questions it aims to answer are: * Is the baroloop device associated with any major medical problems including death? * Does the baroloop lower the blood pressure of study participants? Participants will be implanted with the baroloop device. Afterwards they will visit the clinic after 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months for adjustment of the device settings and/or other study related assessments. Participants will also be asked to answer questions regarding their quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Participants will have the baroloop device implanted for selective stimulation of the vagus nerve.
Clemenshospital Münster
Münster, North Rhine-Westphalia, Germany
RECRUITINGMarienhaus Klinikum Mainz
Mainz, Rhineland-Westphalia, Germany
RECRUITINGStädtisches Klinikum Dresden
Dresden, Saxony, Germany
RECRUITINGUMC Utrecht
Utrecht, Utrecht, Netherlands
RECRUITINGSafety of the baroloop device
Composite Major Adverse Event (MAE) Rate including all-causes of death and all device or procedure-related serious adverse event
Time frame: 6 months after initial stimulation
Performance
Change in mean 24-hour Systolic Ambulatory Blood Pressure (ABP) by ambulatory blood pressure monitoring
Time frame: 6 months after initial stimulation
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