NCT01996033已完成不适用
This is a Post Market, Multi-center, Open Label, Observational Study. Approximately 500 Subjects With Uncontrolled Hypertension Will Undergo Renal Artery Ablation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 12
- 主要终点
- Mean Reduction in Office Systolic Blood Pressure at 6 Months
研究概览
简要总结
The purpose of this observational study is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension in clinical routine practice.
详细描述
This is a post market, multi-center, open label, observational study. Approximately 500 subjects with uncontrolled hypertension will undergo renal artery ablation at approximately 40 investigational sites located in Germany and will be followed for 1 year post procedure.The expected duration of the investigation will be approximately 4 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is planned to undergo a renal denervation procedure for the treatment of hypertension
- •Subject is ≥18 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 (SBP) ≥ 140 mmHg
- •Subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic), or subject has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE-I/ Angiotensin Receptor Blocker (ARB), Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs
排除标准
- •Subject has known significant renovascular abnormalities such as renal artery stenosis > 30%
- •Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
- •Subject has a history of hemodynamically significant valvular heart disease
- •Subject has blood clotting abnormalities
- •Subject life expectancy is < 12 months, as determined by the Study Investigator
- •Subject is participating in another clinical study which has the potential
结局指标
主要结局
Mean Reduction in Office Systolic Blood Pressure at 6 Months
时间窗: 6 months
Positive number indicates a reduction (improvement) in blood pressure
次要结局
未报告次要终点
研究者
研究点 (12)
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