Baroloop Multicenter Trial (Baroloop MCT)

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.
• •11. Symptomatic carotid artery disease or \> 70% occlusion of either carotid artery; any carotid malformation or lesion, a carotid bruit or other abnormal carotid sound.
• •12. Prior surgery, radiation therapy or scarring in the neck in the region of the carotid artery (e.g., patients with a tracheostomy, extensive thymectomy or thyroid surgery).
• •13. Limited mobility of the neck secondary to vertebral disease or prior vertebral surgery, including patients who wear a cervical support.
• •14. History of heart failure (NYHA class III-IV).
• •15. Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require anticoagulation if the condition interferes with a consistent measurement of blood pressure.
• •16. Unexplained syncope in the last 6 months.
• •17. History of bleeding disorders, thrombocytopenia, hemophilia, or significant anemia (hemoglobin (Hgb) \< 10 g/dl).
• •18. Current anticoagulation therapy (excluding antiplatelet therapy with aspirin as a sole therapy).
• •19. History of unresolved drug or alcohol use.
• •20. Active treatment of a psychiatric ailment.
• •21. Life expectancy of less than 12 months due to other disease.
• •22. Subject has a condition that, in the opinion of the investigator, precludes participation, including willingness to comply, with all follow-up procedures.
• •23. Participation in another clinical study for which follow-up is currently on-going.
• •24. Women who are pregnant
• •25. Resting heart rateof \< 45 beats/min s, confirmed at both baseline visits.
• •26. Baroreflex failure or autonomic neuropathy
• •27. Symptomatic, uncontrolled bradyarrhythmias
• •28. Atrioventricular block of any grade
• •29. Presence of a vagus stimulator
• •30. Patients who are likely to require magnetic resonance imaging (MRI) of the cervical area
• •31. Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy
• •32. Patients with a limited ability to read, understand and execute adjustment procedures (for example, persons suffering from dementia).
• •33. Likely exposure to diathermy.