临床试验/NCT01823393

NCT01823393终止4 期

Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure

University Hospital, Montpellier2 个研究点分布在 1 个国家目标入组 94 人开始时间: 2013年1月24日最近更新: 2026年6月12日

适应症

干预措施

试验速览

阶段: 4 期
状态: 终止
发起方: University Hospital, Montpellier
入组人数: 94
试验地点: 2
主要终点: Number of serious complication : vascular, hemorrhagic or ischaemic complication

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

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

•be over 18
•carry a tight and symptomatic aortic stenosis
•have an indication for a ballon aortic valvuloplasty
•Subject have signed his written informed consent

排除标准

•Have an absence of femoral surgical approach
•have a criticial hemodynamic state, considered as outdrove for the treatment
•have a severe aortic failure
•allergia to heparin
•contraindication to heparin or/and local anaesthetic
•be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty
•have a tight but not symptomatic aortic stenosis

研究组 & 干预措施

Heparin

Experimental

injection of unfractionated heparin (50 IU / kg)

干预措施: Heparin (Drug)

NaCl

Placebo Comparator

without heparin

干预措施: NaCl (Drug)

结局指标

主要结局

Number of serious complication : vascular, hemorrhagic or ischaemic complication

时间窗: Up to10 days after the valvuloplasty (D1-D10 after the intervention)

次要结局

number of a serious complication : vascular, hemorrhagic or ischaemic complication(up to 30 days after valvuloplasty)
Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)(up to30 days after the valvuloplasty (until D30 after intervention))

研究者

发起方

University Hospital, Montpellier

申办方类型

Other

责任方

Sponsor

研究点 (2)

Loading locations...

相似试验

进行中（未招募）

1 期

Ballon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedureAortic stenosisMedDRA version: 14.1Level: PTClassification code 10002906Term: Aortic stenosisSystem Organ Class: 10047065 - Vascular disorders

EUCTR2012-003391-39-FRniversity Hospital of Montpellier130

招募中

3 期

Methods of keeping the path of intravenous catheters opePhlebitis.Phlebitis of portal veinK75.1

IRCT20190325043107N4Tabriz University of Medical Sciences60

已完成

不适用

5 Years Follow up of the SAPIEN 3 Valve From the DIRECTAVI TrialCoronary SyndromeHemodynamic Instability

NCT05140317University Hospital, Montpellier236

撤回

不适用

Effects of Percutaneous Aortic Valve Implantation on sympathetic activityaortic valve stenosism aortic valve narrowing10046973

NL-OMON37473Academisch Medisch Centrum60

尚未招募

不适用

Effects of Percutaneous Aortic Valve Implantation on Left Ventricular Function And Coronary Hemodynamicsaortic valve narrowingaortic valve stenosis10046973

NL-OMON33340Academisch Medisch Centrum120