跳至主要内容
临床试验/NCT01888315
NCT01888315Unknown1 期

Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity

University Hospital, Saarland2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
1,000
试验地点
2
主要终点
Safety and efficacy of renal denervation

研究概览

简要总结

The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.

详细描述

Inclusion Criteria

  1. Individual is 18 years of age.
  2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

  1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • Individual is 18 years of age.
  • Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
  • Patient scheduled for renal sympathetic denervation using market-released device.

排除标准

  • In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.
  • Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

结局指标

主要结局

Safety and efficacy of renal denervation

时间窗: Baseline to 6 months

Effect on blood pressure including office, ABPM, and home-based measurements. Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure). Changes of antihypertensive medications. Effects on renal function assessed with glomerular filtration rate. Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.

次要结局

  • Effect of renal denervation on different organ systems.(Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)
  • Safety and efficacy of renal denervation(Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months)

研究者

发起方
University Hospital, Saarland
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Influence of Catheter-based Renal Denervation in... | 临床试验