International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension (EnligHTN III)
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The purpose of this First-in-Human Clinical investigation is to evaluate the safety and performance of the St. Jude Medical EnligHTN™ Generation 2 Renal Denervation System for the treatment of patients with drug-resistant uncontrolled hypertension.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subject is ≥ 18 and ≤ 80 years of age at time of consent
Subject must be able and willing to provide written informed consent
Subject must be able and willing to comply with the required follow-up schedule
Subject has office Systolic Blood Pressure ≥ 160 mmHg at confirmatory visit
Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg during the two week screening period
Subject has an office Systolic Blood Pressure that remains ≥160 mmHg despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic or subject was previously on diuretic but documented to be diuretic intolerant, for a minimum of 14 days prior to the procedure and with an expectation to maintain for a minimum of 180 days post procedure.
Subject has significant renovascular abnormalities such as renal artery stenosis > 30% in either renal artery
Subject has hemodynamically significant valvular heart disease as determined by the Study Investigator
Subject has a life expectancy less than 12 months, as determined by a Study Investigator
Subject is participating in another clinical study which has the potential to impact their hypertension management (pharmaceutical/device/homeopathic)
Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
Subject has active systemic infection
Subject has renal arteries with diameter(s) < 4 mm in diameter or <20 mm in length
Subject has an estimated Glomerular Filtrate Rate (eGFR) <45 mL/min per 1.73 m2 using the Modified Diet in Renal Disease (MDRD) formula
Subject has Diabetes Mellitus Type I
Subject has multiple main renal arteries in either kidney
Subject has an identified secondary cause of hypertension (for example, including, but not limited to, Polycystic kidney disease, Cushing's syndrome, Aldosteronism)
Subject has evidence of significant abdominal aortic aneurysm (defined as maximum diameter of >4 cm)
Subject has had a myocardial infarction, unstable angina pectoris or cerebrovascular accident less than 180 days prior to enrollment
Subject is expected to have cardiovascular intervention within the next 180 days
Subject has a condition which would interfere with the accurate interpretation of the study objectives including but not limited to a large arm diameter that is unable to accommodate the blood pressure cuff or arrhythmia that interferes with automatic pulse sensing.