NCT01836146已完成不适用
International First-in-Human Study of the EnligHTN Generation 2 System in Patients With Drug-resistant Uncontrolled Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 8
- 主要终点
- Performance objective
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Performance objective
时间窗: 6 months
To characterize the reduction of office Systolic Blood Pressure at 6 months post procedure as compared to baseline.
Safety Objective
时间窗: 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).
次要结局
- New renal artery stenosis or aneurysm at the site of ablation(1 month, 3 month, 6 month, 12 month, 18 month, 2 years)
- Change in Ambulatory Blood Pressure(1 month, 3 month, 6 month, 12 month, 18 month, 2 years)
- Renal Function Change(1 month, 3 month, 6 month, 12 month, 18 month, 2 years)
研究者
研究点 (8)
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