NCT01392196终止不适用
Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
研究概览
简要总结
This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure patients NYHA Class II or III
- •Renal Impairment Left Ventricular Ejection Function <40%
- •GFR 30 to 75 mL/min/1.73m2
- •Optimal stable medical therapy
排除标准
- •Renal artery anatomy must be eligible for treatment as determined by Angiography, and
- •History of prior renal artery intervention
- •Single functioning kidney.
- •Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
- •Systolic BP < 90 mmHG
结局指标
主要结局
Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events
时间窗: 6 month
次要结局
- Ventricular function as measured by Echocardiography(6 month)
- Renal function as measured by Glomerular Filtration Rate (GFR)(6 months)
研究者
研究点 (1)
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