Status:
COMPLETED
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
Lead Sponsor:
Abbott Medical Devices
Conditions:
Hypertension
Renal Denervation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01836146
Start Date
April 1 2013
End Date
September 1 2015
Last Update
February 4 2019
Active Locations (6)
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1
St Andrews Hospital
Adelaide, South Australia, Australia
2
St. Vincent's Hospital Melbourne
Fizroy, Victoria, Australia
3
Monash Heart/Southern Health
Melbourne, Victoria, Australia
4
Royal Melbourne Hospital
Melbourne, Victoria, Australia