跳至主要内容
临床试验/EUCTR2012-003391-39-FR
EUCTR2012-003391-39-FR进行中(未招募)1 期

Ballon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedure - HEPAVALV

niversity Hospital of Montpellier0 个研究点目标入组 130 人开始时间: 2012年9月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
130

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients must :
  • - be over 18 and carry a tight and symptomatic aortic stenosis
  • - have an indication for a balloon aortic valvuloplasty
  • - be informed about the study and have given his written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 130
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • Patients must not :
  • - have an absence of femoral surgical approach
  • - have a critical hemodynamic state, considered as outdrove for the treatment
  • - have a severe aortic failure
  • - be allergic to heparin
  • - have a contraindication to the use of heparin
  • - have a contraindication to local anaesthetic
  • - be treated by low molecular weight heparin in less than 12 hours before the valvuloplasty or by standard heparin in less than 4 hours before the valvuloplasty
  • - have a tight but not symptomatic aortic stenosis
  • - be pregnant, breast-feeding, with no rights from the national health insurance programme

研究者

发起方
niversity Hospital of Montpellier

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