hypertension
Conditions
Interventions
None listed
Sponsors
neuroloop GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Aged 18 years or older and less than 80 years of age. • Persistent office systolic blood pressure (SBP) >= 140 mm Hg 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 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 4 antihypertensive medicines consisting of a renin-angiotensin blocker(ACE) or Angiotensin II Receptor Blocker (ARBs), a calcium channel blocker (CCB), and a diuretic for 4 weeks at treatmenta diuretic and spironolactone for 4 weeks at treatment. If spironolactone is not tolerated, the regimen must include instead the addition of further diuretic therapy with either eplerenone, amiloride, higher-dose thiazide/thiazide-like diuretic or a loop diuretic, or the addition of bisoprolol or doxazosin. If none of these medicines are tolerated, then patients on a 3-drug regimen may be included. . The Investigator has confirmed that the patient has already tried and/or is not suitable for treatment with currently CE-marked device-based therapies for resistant hypertension as an alternative to baroloop therapy. • Negative pregnancy test for women of child-bearing age • Willingness and ability to comply with follow-up requirements. • Signed informed consent.
Exclusion criteria
Exclusion criteria: • 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). . 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 10%). • One or more episodes of orthostatic hypotension in the past year • Requirement for chronic oxygen therapy or mechanical ventilation. • 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% occlusion of either carotid artery ; any carotid malformation or lesion, a carotid bruit or other abnormal carotid sound. . 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 or ejection fraction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4.2. Primary Study Endpoints 4.2.1. Safety Composite Major Adverse Event (MAE) Rate at six (6) months post-treatment including: • All-causes of death • Hospitalization for hypertensive crisis post-titration • Any device or procedure-related serious adverse event All MAEs will be adjudicated by an independent Data Safety Management Board (DSMB) 4.2.2. Feasibility The ability of the baroloop System to be placed around a vagal nerve and to stimulate at Day14/21 post-implantation. . | — |
Secondary
| Measure | Time frame |
|---|---|
| 4.3. Secondary Study Endpoints 4.3.1. Efficacy: • The change in blood pressure recorded during intraoperative stimulation at the time of implantation. • Mean reduction in 24-hour ambulatory systolic and diastolic blood pressure (ambulatory blood pressure monitoring - ABPM) at one (1), three (3), six (6), twelve (12) and eighteen (18) and twenty-four (24) months post-treatment versus baseline. • The composite MAE rate at 1, 3, 6, 12, 18 and 24 months post-procedure defined as: o All-causes of death o Hospitalization for hypertensive crisis post-titration o Any device or procedure-related serious adverse event • The mean reduction in office diastolic and systolic blood pressure, and diastolic and systolic blood pressure at 1, 3, 6, 12, 18, and 24 months. • Changes in antihypertensive medicines/doses through 1, 3, 6, 12, 18 and 24 months post-implantation as analyzed by Daily Defined Dosages (WHO Definition) and total medications. • Quality of Life as measured by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). | — |
Countries
Netherlands
Outcome results
None listed