refractory high blood pressure therapy-resistent hypertension
Conditions
Interventions
The Rheos System is implanted during an operation procedure, which takes place
in an operation room under general or local anesthesia. The carotid bifurcation
is exposed at both sides and the electr
Sponsors
CVRx Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Ten minste 21 jaar en niet ouder dan 80 jaar Office blood pressure equal or above 160/80 mmHg Ambulatory 24-hour systolic blood pressure equal or above 135 mmHg Normal anatomy of carotid artery bifurcations Full doses of anti-hypertensive treatment (3 medication with 1 diuretic) Compliant to therapy Not pregnant or contemplating pregnancy during study period
Exclusion criteria
Exclusion criteria: Known or suspected baroreflex failure or autonomic neuropathy Body Mass Index above 45 Myocardial infarction, unstable angina, syncope or CVA within the past 3 months Carotid atherosclerosis producing a 50% or greater reduction in diameter Prior surgery, radiation or endobvascular stent placement in carotid sinus region Severe chronic kidney disease, estimated GFR below 30 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate a clinically significant reduction of office cuff systolic BP at six months post-activation. A clinically significant reduction in office cuff systolic BP is defined as a 10 mm Hg or greater reduction, and the proportion of subjects meeting this success criterion at the trial endpoint will be compared across treatment groups. 2. To demonstrate a sustained response to therapy through 12 months post-activation. Responders at six months post-activation (defined as randomized to the ON arm and experiencing at least a 10 mmHg reduction in systolic BP) will be analyzed at 12 months to determine if the 10 mmHg reduction is sustained and if the response at 12 months is at least 50% of the response observed at 6 months. 3. To demonstrate the acute safety of Rheos therapy in the treatment of hypertension by evaluating all system and procedure related adverse events occurring in the first 30 days post-implant. 4. To demonstrate the long-term safety of Rheos therapy in the treatment of hypertension by evaluating all major hypertension-related adverse events and serious device-related adverse events occurring more than 30 days post-implant to 13 months post-implant. 5. To demonstrate the safety of Rheos therapy activation through 6 months post-implant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare changes between the Rheos ON and Rheos OFF arms in antihypertensive therapeutic index (ATI) at six months post-activation. 2. To demonstrate a clinically significant reduction of 24-hour ambulatory systolic BP at six months post-activation. A clinically significant reduction in 24-hour ambulatory systolic BP is defined as a 7 mm Hg or greater reduction, and the proportion of subjects meeting this success criterion at six months post-activation will be compared across treatment groups. 3. To demonstrate a significant absolute reduction in systolic BP at six months postactivation, as measured by office cuff. 4. To demonstrate a significant absolute reduction in 24-hour ambulatory systolic BP at six months post-activation. 5. To further demonstrate sustained response to therapy by evaluating an immediate (randomized to ON) vs deferred (randomized to OFF) therapy comparison of average absolute reduction in systolic BP as measured by office cuff at 12 months post-activation. | — |
Countries
Netherlands
Outcome results
None listed