A Study of Non-Vascular Renal Denervation Using the Verve Medical Phoenix ™ System

Exclusion Criteria

• •Females who are either pregnant or breastfeeding.
• •Office SBP or DBP ≥180/110 mmHg.
• •Untreated urinary tract infection.
• •Renal collecting system is compromised, and subject cannot undergo routine cystoscopy and retrograde pyelogram.
• •Dialysis patients.
• •Renal transplant patients.
• •Subjects on the following medications, clonidine, guanfacine and methyldopa.
• •Known secondary causes of hypertension such as adrenal disease, renal artery stenosis, renovascular hypertension.
• •Subjects with glomerulonephritis or interstitial nephritis or eGFR \< 45 ml/min/1.73m2.
• •Type I diabetes mellitus.
• •Stenotic valvular heart disease for which reduction of blood pressure would be hazardous.
• •Subjects with orthostatic hypotension.
• •Myocardial infarction, unstable angina, or stroke in the prior 6 months.
• •Any medical condition (including psychiatric disease) that would interfere with conducting the study or would not be in the best interest of the subject.
• •Inability of the subject to provide informed consent.
• •Subjects with sleep apnea.
• •Patients taking any drugs that affect blood pressure through off target effects
• •Patients with any clinical condition that can affect blood pressure or require the use of drugs that can affect blood pressure. e.g. NSAIDs, steroids, cold remedies.
• •Patients who may require any procedure that can affect blood pressure.
• •Patients who work a night shift.