RecruitingNot ApplicableNCT06518915

Baroloop Multicenter Trial (Baroloop MCT)

Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop


Sponsor

neuroloop GmbH

Enrollment

120 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a small device called the Baroloop, which is placed around a nerve in the neck to help lower blood pressure in people whose high blood pressure hasn't responded to medication. **You may be eligible if...** - You are 18 or older - Your blood pressure is still high (140/90 or above) even while taking 3 blood pressure medications - You have been on a stable combination of an ACE inhibitor or ARB, a calcium channel blocker, and a diuretic for at least 4 weeks - Your 24-hour blood pressure monitor confirms high blood pressure **You may NOT be eligible if...** - You have a pacemaker or implanted defibrillator - You have had neck surgery, radiation to the neck, or significant scarring in the neck area - You have had a stroke or mini-stroke in the past 6 months - Your BMI is above 40 or you have severe blockage in your carotid arteries - You have severe heart failure, untreated sleep apnea, or poorly controlled type 2 diabetes - You are pregnant - You already have a vagus nerve stimulator - Your resting heart rate is below 45 beats per minute Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEbaroloop system

Participants will have the baroloop device implanted for selective stimulation of the vagus nerve.


Locations(4)

Clemenshospital Münster

Münster, North Rhine-Westphalia, Germany

Marienhaus Klinikum Mainz

Mainz, Rhineland-Westphalia, Germany

Städtisches Klinikum Dresden

Dresden, Saxony, Germany

UMC Utrecht

Utrecht, Utrecht, Netherlands

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NCT06518915


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