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Baroloop Multicenter Trial (Baroloop MCT) | Clinical Trials | Clareo Health

RECRUITINGNA

Baroloop Multicenter Trial (Baroloop MCT)

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

NCT06518915•neuroloop GmbH

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older.
•2. Persistent office systolic blood pressure (SBP) ≥ 140 mm Hg and diastolic blood pressure (DBP) \> 90 mm Hg on antihypertensive medicines on two visits separated by a minimum of four weeks.
•3. Mean 24-hour systolic ABPM ≥ 130 mm Hg and mean 24 hour diastolic ABPM ≥ 80 mm Hg conducted after direct observed therapy to confirm that antihypertensive medicines were taken as prescribed during the ABPM measurement.
•4. Stable drug regimen of 3 antihypertensive medicines consisting of a reninangiotensin blocker (ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for 4 weeks at treatment.
•5. Willingness and ability to comply with follow-up requirements.
•6. Signed informed consent.

Exclusion Criteria

•1. Any patient in whom access to the vagal nerve is limited by the size of the vagus (a size not compatible with the baroloop cuff).
•2. Any patient with a history of injury to the vagus nerve or its branches (e.g., the recurrent laryngeal nerve).
•3. Secondary causes of hypertension.
•4. Calculated eGFR \< 30 mL/min/1.73m2.
•5. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c \> 10%).
•6. Requirement for chronic oxygen therapy or mechanical ventilation.
•7. Untreated (no CPAP therapy) sleep apnea (AHI \> 15)
•8. Morbid obesity, defined as Body Mass Index \>40 kg/m2 or arm circumference 46 cm.
•9. Pacemaker and/or implantable defibrillators.
•10. History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening.
+23 more criteria

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

Key Dates

Start Date

May 22, 2024

Primary Completion Date

May 1, 2029

Completion Date

December 1, 2031

Last Updated

April 17, 2025

Enrollment

120

ESTIMATED participants

Conditions

Hypertension, Resistant to Conventional Therapy

Interventions

baroloop system

DEVICE

Contacts

Medical Scientific Affairs

CONTACT

+49 761 1543390 study@neuroloop.de

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COMPLETEDNA

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Baroloop Multicenter Trial (Baroloop MCT)

Inclusion Criteria

Exclusion Criteria

Moderato System in Patients With Hypertension

Peripheral Chemoreflex/Arterial Baroreflex Interaction in Patients With Electrical Carotid Sinus Stimulation

The Use of Ambulatory Blood Pressure Monitors to Assess Angiotensin Converting Enzyme Inhibitors

Addition of Homeopathy in Patients With Resistant Arterial Hypertension

Autonomic Dysfunction in Resistant Hypertension