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RECRUITING
NCT06518915
NA

Baroloop Multicenter Trial (Baroloop MCT)

Sponsor: neuroloop GmbH

View on ClinicalTrials.gov

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.

Official title: Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-05-22

Completion Date

2031-12

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DEVICE

baroloop 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