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2012年9月24日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Aortic stenosis
- 发起方
- niversity Hospital of Montpellier
- 入组人数
- 130
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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