What is the baroloop device studying for resistant hypertension?

The baroloop device is being studied to see if it is safe and if it can help lower blood pressure in adults whose hypertension does not respond well to medication. This clinical trial aims to understand the device's safety and performance over time through regular monitoring by the sponsor neuroloop GmbH. Participants will be closely observed to assess any medical issues and blood pressure changes.

Who may be eligible for this hypertension clinical trial?

Adults aged 18 years or older with persistent high blood pressure despite taking specific medications may be eligible. Participants must be willing to follow the study plan and not have conditions like vagus nerve injury or pregnancy. Please review eligibility criteria for more details.

Is there any cost to participate in this hypertension clinical trial?

Study-related care, including the implanted baroloop device and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be reimbursed. Participants should plan accordingly for any travel needs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06518915

Study of Safety and Effectiveness of the Baroloop Device for Treating Resistant Hypertension in Adults

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

120

Participants Needed

Research Sites

134 weeks

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Medical Scientific Affairs

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