Rheos(TM) Pivotal Trial, a Study of Baroreflex Hypertension Therapy in Refractory Hypertension. Amendment 1: Dynamic cerebral autoregulation and lacol pulsewave velocity. Amendment 2: Investigational Plan , revision D Amendment 3: Investigational Plan, revision E Amendment 4: Investigational Plan, revision F
- Conditions
- refractory high blood pressuretherapy-resistent hypertension10057166
- Registration Number
- NL-OMON38362
- Lead Sponsor
- CVRx Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method