Hypertensie High blood pressure hypertension
Conditions
Interventions
Through a puncture of the groin (under local anesthesia) a catheter is advanced
towards the renal artery around which several nerves are located which play an
important role in the control of blood
Hypertension
Renal nerve mapping
Sponsors
Pythagoras Medical Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Signed written informed consent. - Age >18 years and 45. - A patient who is mentally competent with the ability to understand and comply with the requirements of the study. - The patient agrees to attend all follow-up evaluations and is willing to complete required exams and tests.
Exclusion criteria
Exclusion criteria: - Previous participation in another study with any investigational drug or device within the past 30 days. - Relevant renal artery disease (% diameter stenosis>30%, aneurysm or fibromuscular dysplasia). - Known secondary causes of hypertension. - The patient has a life expectancy * 12 months. - The patient has undergone prior renal denervation, renal stenting, and/or abdominal aortic stent grafts. - The patient has chronic oxygen use other than nocturnal support for sleep apnea. - The patient has type I diabetes mellitus. - The patient has had a previous organ transplant or is awaiting a renal transplant. - Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator). - The patient has triple ipsilateral artery ostia. - Moderate to severe valvular heart disease. - The patient has other concomitant conditions that may adversely affect the patient or the study outcome. - Female who is pregnant, nursing or planning to become pregnant. - Documented contraindication or allergy to contrast medium not amenable to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of serious adverse events (system and/or procedure related events). | — |
Secondary
| Measure | Time frame |
|---|---|
| Arterial blood pressure changes to renal nerve stimulation. | — |
Countries
Greece
Outcome results
None listed