Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06518915

Baroloop Multicenter Trial (Baroloop MCT)

Led by neuroloop GmbH · Updated on 2025-04-17

120

Participants Needed

4

Research Sites

392 weeks

Total Duration

On this page

Sponsors

N

neuroloop GmbH

Lead Sponsor

A

Avania

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Baroloop Multicenter Trial (Baroloop MCT)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older.
  • 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 at least four weeks.
  • Mean 24-hour systolic ambulatory blood pressure monitoring (ABPM) ≥ 130 mm Hg and mean 24-hour diastolic ABPM ≥ 80 mm Hg after confirmed observed therapy.
  • Stable drug regimen of three antihypertensive medicines including a renin-angiotensin blocker (ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for four weeks.
  • Willingness and ability to comply with follow-up requirements.
  • Signed informed consent.
Not Eligible

You will not qualify if you...

  • Limited access to the vagal nerve due to size incompatible with the baroloop cuff.
  • History of injury to the vagus nerve or its branches.
  • Secondary causes of hypertension.
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2.
  • Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 10%).
  • Need for chronic oxygen therapy or mechanical ventilation.
  • Untreated sleep apnea (AHI > 15).
  • Morbid obesity (Body Mass Index > 40 kg/m2) or arm circumference over 46 cm.
  • Presence of pacemaker or implantable defibrillators.
  • History of stroke or transient ischemic attack within six months before screening.
  • Symptomatic carotid artery disease or significant carotid artery occlusion.
  • Prior neck surgery, radiation, or scarring near carotid artery.
  • Limited neck mobility due to vertebral disease or surgery.
  • History of severe heart failure (NYHA class III-IV).
  • Cardiac arrhythmias requiring anticoagulation that interfere with blood pressure measurement.
  • Unexplained fainting in last six months.
  • History of bleeding disorders or significant anemia (hemoglobin < 10 g/dl).
  • Current anticoagulation therapy (except aspirin alone).
  • History of unresolved drug or alcohol use.
  • Active psychiatric treatment.
  • Life expectancy under 12 months due to other diseases.
  • Conditions precluding participation or follow-up compliance.
  • Participation in another ongoing clinical study.
  • Pregnancy.
  • Resting heart rate under 45 beats per minute.
  • Baroreflex failure or autonomic neuropathy.
  • Uncontrolled bradyarrhythmias.
  • Any grade of atrioventricular block.
  • Presence of another vagus stimulator.
  • Likely need for cervical MRI.
  • Occupational exposure to high levels of non-ionizing radiation.
  • Cognitive limitations affecting ability to follow procedures.
  • Likely exposure to diathermy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Clemenshospital Münster

Münster, North Rhine-Westphalia, Germany, 48153

Actively Recruiting

2

Marienhaus Klinikum Mainz

Mainz, Rhineland-Westphalia, Germany, 55131

Actively Recruiting

3

Städtisches Klinikum Dresden

Dresden, Saxony, Germany, 01067

Actively Recruiting

4

UMC Utrecht

Utrecht, Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

M

Medical Scientific Affairs

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Baroloop Multicenter Trial (Baroloop MCT) | DecenTrialz