NCT00551304已完成1 期
Native Kidney Denervation in Patients With End Stage Renal Disease
Medtronic Vascular3 个研究点 分布在 2 个国家开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 3
- 主要终点
- To provide confirmation that renal denervation in ESRD patients is safe and feasible.
研究概览
简要总结
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult >= 18 years of age
- •end stage renal disease, undergoing concurrent dialysis treatment
- •poorly controlled blood pressure on at least 2 antihypertensive drugs
- •agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
- •competent and willing to provide written, informed consent to participate in this clinical study.
排除标准
- •renal arterial abnormalities
- •myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
- •hemodynamically significant valvular heart disease
- •implantable cardioverter defibrillator (ICD) or pacemaker
- •respiratory support.
- •pregnant, nursing or planning to be pregnant
结局指标
主要结局
To provide confirmation that renal denervation in ESRD patients is safe and feasible.
次要结局
- To provide evidence of denervation, indication of physiologic response, and assess device performance.
研究者
研究点 (3)
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