International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
- Conditions
- HypertensionRenal Denervation
- Interventions
- Device: EnligHTN™ Renal Artery Ablation Catheter
- Registration Number
- NCT01836146
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal Artery Ablation EnligHTN™ Renal Artery Ablation Catheter -
- Primary Outcome Measures
Name Time Method Performance objective 6 months To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.
Safety Objective 6 months To characterize the rate of serious procedural and device related adverse events from date of procedure through 6 months post procedure, as adjudicated by the Clinical Events Committee (CEC).
- Secondary Outcome Measures
Name Time Method New renal artery stenosis or aneurysm at the site of ablation 1 month, 3 month, 6 month, 12 month, 18 month, 2 years Characterization of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation over time as compared to baseline
Change in Ambulatory Blood Pressure 1 month, 3 month, 6 month, 12 month, 18 month, 2 years Characterization of the change in Ambulatory Blood Pressure parameters over time as compared to baseline
Renal Function Change 1 month, 3 month, 6 month, 12 month, 18 month, 2 years Characterization of renal function change over time as compared to baseline as measured by changes in: eGFR, serum creatinine and cystatin C
Trial Locations
- Locations (6)
Auckland City Hospital
🇳🇿Auckland, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Monash Heart/Southern Health
🇦🇺Melbourne, Victoria, Australia
St. Vincent's Hospital Melbourne
🇦🇺Fizroy, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
St Andrews Hospital
🇦🇺Adelaide, South Australia, Australia