ConfidenHT System for Diagnostic Electrical Mapping of Renal Nerves

To evaluate the safety and performance of the ConfidenHT System for diagnostic mapping of renal nerves; functional distribution of renal nerves and the effect of renal nerve stimulation on the blood pressure

Inclusion criteria

• Signed written informed consent.
• Age >18 years and <75.
• Either:

• Hypertensive patients planned to undergo elective cardiac catheterization
• Potential candidates for renal sympathetic denervation
• Main renal artery with diameter ≥ 4.0mm.
• Glomerular Filtration Rate (GFR) >45 mL/min
• 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.
• Female patients with childbearing potential must agree:

• to use a valid method of contraception (oral contraceptives, intrauterine device, subcutaneous contraceptive implant, vaginal ring)
• to perform a pregnancy test

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.