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临床试验/CTRI/2017/08/009355
CTRI/2017/08/009355已完成不适用

Comparison of right ventricular function between trans right atrial versus trans right right atrial/right ventricular approach for Tetralogy of Fallot repair

The Director of AIIMS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年1月9日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Right Ventricular Function using TAPSE

研究概览

简要总结

Comparisonof right ventricular function between trans right atrial versus trans rightatrial/right ventricular approach for Tetralogy of Fallot repair

The approach for surgery for Tetralogy of Fallot has evolved from purelytrans right ventricular approach to purely trans right atrial approach.  Trans right atrial/right ventricular approachhad been the choice for majority of cardiothoracic surgeons wherein the rightatrial was used to close to the ventricular septal defect and rightventriculotomy was used for resection of infundibulum. The trans RA/RV approachis said to be inferior to the Trans RA approach with respect to incidence ofpost-operative arrhythmias, right ventricular dysfunction and sudden death. Theright atrial approach has a long learning curve and has been known to leavebehind residual right ventricular tract obstruction. This study aims to compareoutcome of the trans-right atrial versus trans right atrial/right ventricularapproaches vis-à-vis their effect on right ventricular function.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
6.00 Month(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • Those eligible for intracardiac repair of Tetralogy of Fallot.

排除标准

  • Children undergoing trans annular patch or concomitant pulmonary artery procedures, emergency surgery or parents who do not consent for participation.

结局指标

主要结局

Right Ventricular Function using TAPSE

时间窗: Before operation | Every one day | After 30 days post op

次要结局

  • Death(ICU stay)

研究者

发起方
The Director of AIIMS
申办方类型
Research institution and hospital

研究点 (1)

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