Clinical trial NCT01836146: International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Renal Denervation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-04-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Subject has significant renovascular abnormalities such as renal artery stenosis \> 30% in either renal artery
* Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
* 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.

Primary outcomes:
measure: Safety Objective
timeFrame: 6 months
measure: Performance objective
timeFrame: 6 months
Secondary outcomes:
measure: Change in Ambulatory Blood Pressure
timeFrame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
measure: New renal artery stenosis or aneurysm at the site of ablation
timeFrame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
measure: Renal Function Change
timeFrame: 1 month, 3 month, 6 month, 12 month, 18 month, 2 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: St Andrews Hospital
state: South Australia
city: Fizroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Monash Heart/Southern Health
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
Study officials:
References: