Hypertension, Renal Denervation
Conditions
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.
Interventions
DEVICEEnligHTN™ Renal Artery Ablation Catheter
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Performance objective | 6 months | To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Australia, New Zealand
Outcome results
None listed