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
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终止
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