Actively Recruiting
Baroloop MCT - A Multicenter Trial of Safety and Performance of Baroloop
Led by neuroloop GmbH · Updated on 2025-04-17
120
Participants Needed
4
Research Sites
134 weeks
Total Duration
On this page
Sponsors
N
neuroloop GmbH
Lead Sponsor
A
Avania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the baroloop system, a device implanted to stimulate the vagus nerve, for treating adults with hypertension that does not respond well to medication. The study aims to find out if the baroloop is safe, including checking for serious medical problems or death, and if it effectively lowers blood pressure in participants. This is a multicenter clinical trial sponsored by neuroloop GmbH. Participants will have the baroloop device implanted and will attend follow-up visits at 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months after implantation. During these visits, device settings may be adjusted, and various assessments related to the study will be performed. Participants will also answer questions about their quality of life throughout the study period. During the trial, researchers will monitor safety and performance outcomes, especially focusing on safety and blood pressure changes 6 months after stimulation begins. Participants will undergo regular clinical evaluations and provide feedback on their well-being. The total duration of participation includes multiple visits over two years, ensuring close monitoring and adjustment of the device as needed.
CONDITIONS
Brief Title
Baroloop Multicenter Trial (Baroloop MCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Persistent office systolic blood pressure \u2265 140 mm Hg and diastolic blood pressure > 90 mm Hg on antihypertensive medicines on two visits at least four weeks apart
- Mean 24-hour systolic ABPM \u2265 130 mm Hg and mean 24-hour diastolic ABPM \u2265 80 mm Hg after observed therapy
- Stable drug regimen of 3 antihypertensive medicines including a renin-angiotensin blocker (ACE or ARBs), a calcium channel blocker, and a diuretic for 4 weeks
- Willingness and ability to comply with follow-up requirements
- Signed informed consent
You will not qualify if you...
- Limited access to the vagus nerve due to size incompatible with the baroloop cuff
- History of injury to the vagus nerve or its branches
- Secondary causes of hypertension
- Calculated eGFR < 30 mL/min/1.73m2
- Type 1 diabetes or poorly controlled type 2 diabetes (HbA1c > 10%)
- Requirement for chronic oxygen therapy or mechanical ventilation
- Untreated sleep apnea with AHI > 15
- Morbid obesity (BMI > 40 kg/m2 or arm circumference 46 cm)
- Pacemaker or implantable defibrillators
- Recent transient ischemic attack or cerebrovascular accident within 6 months
- Symptomatic carotid artery disease or > 70% occlusion
- Prior surgery, radiation, or scarring in neck carotid area
- Limited neck mobility due to vertebral disease or surgery
- History of severe heart failure (NYHA class III-IV)
- Cardiac arrhythmias requiring anticoagulation affecting blood pressure measurement
- Unexplained syncope in last 6 months
- Bleeding disorders or significant anemia (Hgb < 10 g/dl)
- Current anticoagulation therapy (except aspirin alone)
- History of unresolved drug or alcohol use
- Active psychiatric treatment
- Life expectancy under 12 months
- Conditions limiting compliance with follow-up
- Participation in another ongoing clinical study
- Pregnancy
- Resting heart rate < 45 beats/min at baseline
- Baroreflex failure or autonomic neuropathy
- Symptomatic, uncontrolled bradyarrhythmias
- Any grade of atrioventricular block
- Presence of a vagus stimulator
- Likely need for MRI of cervical area
- High occupational exposure to non-ionizing radiation
- Limited ability to read, understand, or perform device adjustments
- Likely exposure to diathermy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with recovery period
Participants will have the baroloop device implanted for selective stimulation of the vagus nerve.
1 implantation visit and several follow-up visits over 6 months
Duration - Up to 6 months after initial stimulation
Participants are monitored for safety and performance of the baroloop device after implantation.
Regular follow-up visits during the 6 months post-implantation
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
Research Team
M
Medical Scientific Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here