refractory high blood pressure therapy-resistant hypertension
Conditions
Interventions
The Neo System is implanted during an operation procedure, which takes place in
an operating room under general or local anesthesia. The electrode is wrapped
around the carotic sinus at one side of
Sponsors
CVRx Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age at least 21 years and no more than 80 years. Office cuff systolic blood pressure (SBP) >= 140 mmHg Normal anatomy of carotic artery bifurcations An optimal stable anti-hypertensive therapy not pregnant and contemplating pregnancy during study period compliant on therapy
Exclusion criteria
Exclusion criteria: known of suspected baroreflex failure or autonomic neuropathy Body Mass Index above 45 Myocardial Infarction, unstable angina, syncope or CVA within the past 3 months Carotic atherosclerosis producing a 50% or greater reduction in diameter Prior surgery, radiation, or endovascular stent placement in the carotid sinus region Hypertension secondary to an identifiable and treatable cause other than sleep apnoea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the reductions in office cuff systolic blood pressure through six months of Baroreflex Activation Therapy® with the Neo system, relative to the screening blood pressure measurements. To describe the safety of Baroreflex Activation Therapy utilizing the Neo system in the treatment of hypertension by evaluating all adverse events and estimating the rate of all system and procedure related complications through the 6-month visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| NVT | — |
Countries
Netherlands
Outcome results
None listed