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临床试验/NCT05748431
NCT05748431尚未招募不适用

The Outcome of Percutaneous Balloon Pulmonary Valvuloplasty in Pediatrics

Assiut University0 个研究点目标入组 100 人开始时间: 2023年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit

研究概览

简要总结

evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the Pediatric Cardiology Unit.

详细描述

Pulmonary valve stenosis (PS) is a heart valve disorder in which outflow of blood from the right ventricle of the heart is obstructed at the level of the pulmonic valve. Although most commonly diagnosed and treated in the pediatric population, individuals with more severe forms of PS are surviving into adulthood and require ongoing assessment and cardiovascular care. The prevalence of valvular pulmonary stenosis has been reported at 0.6 to 0.8 cases per 1000 live births. When associated with other congenital heart disorder, it occurs in approximately 50% of all born with some kind of congenital heart disease . Pulmonary stenosis can be due to isolated valvular (90%), subvalvular, or peripheral (supravalvular) obstruction, or it may be found in association with congenital heart disorders of some other kind .

Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which requires immediate treatment . Unlike older children with isolated PS, neonates with critical PS presents with severe cyanosis and the suprasystemic right ventricle (RV) pressure may result in RV dilatation and failure with severe tricuspid regurgitation (TR). Since the discovery of balloon pulmonary valvuloplasty (BPV), it has replaced surgical approach for relieving PS . Femoral vein is the most common venous access for BPV; however, crossing the pulmonary valve using this approach can be difficult, especially in the presence of severe TR and right chambers dilatation . This problem can be overcome by using transjugular approach, yet many operators are reluctant to use this method because of potential complications and lack of data reporting transjugular approach. Balloon pulmonary valvuloplasty (BPV) is a safe and effective treatment for isolated pulmonary valve stenosis . The optimal age or body size for elective BPV depends on an individual's pulmonary valve diameter, transpulmonary pressure gradient, and femoral vessel size. Selecting a balloon with an appropriate profile also affects outcomes. An ideal balloon catheter for BPV in younger, smaller patients would have a low profile with a short, round shoulder to lessen the risk of valvular or vascular injury . Balloon pulmonary valvuloplasty provides long-term relief of stenosis of the pulmonary valve in the majority of patients with moderate to severe pulmonary valve stenosis.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
1 Day 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with valvular pulmonary stenosis confirmed by Echocardiography, and managed with percutaneous balloon pulmonary valvuloplasty

排除标准

  • Cases with pulmonary stenosis not candidate for balloon valvuloplasty Cases with pulmonary stenosis associated with other congenital heart diseases

结局指标

主要结局

To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit

时间窗: 3 years

Evaluation depend on Echocariography measurement of pressure gradient pre and post valvuloplasty for about 100 cases of children up to 6 years in the pediatric cardiology y

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Tarek Mohammed Hafez

Principle investigator

Assiut University

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