NCT02006758已完成不适用
EnligHTN European Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 13
- 主要终点
- Mean Change 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 participants with uncontrolled hypertension in clinical routine practice.
详细描述
The EnligHTN European Observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 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)
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 to impact his/her 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 known renal arteries with diameter(s) < 4 mm
- •Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
- •Subject had a renal transplant or is awaiting a renal transplant
结局指标
主要结局
Mean Change in Office Systolic Blood Pressure at 6 Months
时间窗: Baseline and 6 months
次要结局
- Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure(30 days)
- Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month(Baseline and 1 month)
- Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month(1 month)
- Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months(Baseline and 6 months)
- Mean Change in Ambulatory Systolic Blood Pressure at 12 Months(Baseline and 12 months)
- Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months(6 months)
- Mean Change in Office Systolic Blood Pressure at 1 Month(Baseline and 1 month)
- Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months(Baseline and 12 months)
- Mean Change in Ambulatory Systolic Blood Pressure at 6 Months(Baseline and 6 months)
- Mean Change in Office Diastolic Blood Pressure at 1 Month(Baseline and 1 month)
- Mean Change in Ambulatory Systolic Blood Pressure at 1 Month(Baseline and 1 month)
- Renovascular Safety at 6 Months (Renal Artery Stenosis)(6 months)
- Mean Change in Office Systolic Blood Pressure at 12 Months(Baseline and 12 months)
- Mean Change in Office Diastolic Blood Pressure at 6 Months(Baseline and 6 months)
- Mean Change in Office Diastolic Blood Pressure at 12 Months(Baseline and 12 months)
- Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months(Baseline and 6 months)
- Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months(Baseline and 12 months)
- Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months(12 months)
研究者
研究点 (13)
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