Resistent hypertension High blood pressure
Conditions
Interventions
Patients enrolled in the baroloop MCT will have the baroloop device implanted.
The implantable pulse generator (IPG) is implanted subcutaneously in the left
upper chest outside the rib cage, and the
Sponsors
neuroloop GmbH
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Aged 18 years or older.Persistent office systolic blood pressure (SBP) = 140 mm Hg and/or diastolic blood pressure (DBP) =90 mm Hg on antihypertensive medicines on two visits separated by a minimum of four weeks.Mean 24-hour systolic ABPM = 130 mm Hg and/or 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.Stable drug regimen of = 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator, for at least 4 weeks prior to the implanatation procedure. Beta-blockers used to treat other conditions (ie, migraine, heart failure, coronary artery disease) should not be counted as an antihypertensive medication for the purpose of qualifying for this study.Willingness and ability to comply with follow-up requirements.Signed informed consent.
Exclusion criteria
Exclusion criteria: Any patient with a history of injury to the vagus nerve or its branches (e.g., the recurrent laryngeal nerve).Secondary causes of hypertension.Calculated eGFR < 30 mL/min/1.73m2.Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1c > 10%).Requirement for chronic oxygen therapy or mechanical ventilation.Previously untreated (no CPAP therapy) sleep apnea (AHI > 15) Morbid obesity, defined as Body Mass Index >40 kg/m2 or arm circumference 46 cm.Pacemaker and/or implantable defibrillators.History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening.Symptomatic carotid artery disease or =70% stenosis of either carotid artery or carotid malformation. In subjects with a known or suspected lesion, or in whom a carotid bruit or other abnormal carotid sound is detected on physical examination, carotid duplex ultrasonography must be performed to confirm the absence of =70% carotid artery stenosis and carotid malformation 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).Limited mobility of the neck secondary to vertebral disease or prior vertebral surgery, including patients who wear a cervical support.History of heart failure (NYHA class III-IV).Cardiac arrythmias (atrial fibrillation, atrial flutter, etc.) that require anticoagulation if the condition interferes with a consistent measurement of blood pressure.Unexplained syncope in the last 6 months.History of bleeding disorders, thrombocytopenia, hemophilia, or significant anemia (hemoglobin (Hgb) < 10 g/dl).Current anticoagulation therapy with the exception of sole antiplatelet therapy or long-term (12 months minimum), stable, low-dose anticoagulation regime.History of unresolved drug or alcohol abuse.Active treatment of a psychiatric ailment.Life expectancy of less than 12 months due to other disease.Subject has a condition that, in the opinion of the investigator, precludes participation, including willingness to comply with all follow-up procedures.Participation in another medical device or medicinal product study for which follow-up is currently ongoing.Renal denervation less than 6 months before Baseline Visit 1.Women who are pregnant.Resting heart rate of <45 beats/min, confirmed at both baseline visits.Baroreflex failure or autonomic neuropathy. Symptomatic, uncontrolled bradyarrhythmias. Atrioventricular block of Grade II or III. Presence of a vagus stimulator.Patients for whom magnetic resonance imaging (MRI) is planned at the time of enrollment. Occupational exposure to high levels of non-ionizing radiation that may interfere with therapy. Patients with a limited ability to read, understand and execute adjustment procedures (for example, persons suffering from dementia).Likely exposure to diathermy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Composite Major Adverse Event (MAE) Rate at six (6) months including: • All causes of death • All device or procedure-related serious adverse event All MAEs to be adjudicated by an independent Data Safety Management Board (DSMB). Primary Performance Endpoint: Change in mean 24-hour systolic Ambulatory Blood Pressure Monitoring (ABPM) from Baseline and 6 months after first stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in mean 24-hour ambulatory systolic and diastolic blood pressure (ambulatory blood pressure monitoring - ABPM) at one (1), three (3), twelve (12), eighteen (18) and twenty-four (24) months after initial stimulation versus baseline. • The composite MAE rate at 12 and 24 months • Change in mean office diastolic and systolic blood pressure at 1, 3, 6, 12, 18, and 24 months after initial stimulation versus baseline. • Change in mean 24-hour ambulatory nocturnal or waking systolic and diastolic blood pressure (ambulatory blood pressure monitoring - ABPM) at one (1), three (3), twelve (12), eighteen (18) and twenty-four (24) months after initial stimulation versus baseline. • Changes in antihypertensive medicines/doses through 1, 3, 6, 12, 18 and 24 months as analyzed by Daily Defined Dosages (WHO Definition) and total medications after initial stimulation versus baseline. • Quality of Life as measured by the Medical Outcomes Study 36-Iterm Short-Form Health Survey (SF-36) through 3, 6, 12 18 and 24 months after initial stimulation versus baseline. | — |
Countries
Germany, Hungary, Netherlands, Poland, Spain
Contacts
Public ContactA Heile
Avania
Outcome results
None listed