跳至主要内容
临床试验/NCT03567668
NCT03567668Unknown不适用

Individualized Surgical Repair for Congenital Mitral Insufficiency in Infants and Children

Hong Liu1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Recurrence-free survival

研究概览

简要总结

Congenital mitral insufficiency is one of the most common valvular diseases in the pediatric population worldwide, carrying a high morbidity and mortality risk if not treated immediately and properly. Given that mitral replacement likely increased risk of cardiac dysfunction and mitral reoperation, mitral repair is the currently preferred surgical strategy in the majority of pediatric patients with mitral insufficiency. Unfortunately, previous evidences demonstrated the long-term hemodynamic alteration in response to significant mitral regurgitant might lead to a reversible or irreversible pulmonary vascular remodeling regardless of concomitant other cardiac malformations, which is associated with increased risk of morbidity and mortality following the surgery. Currently available researches mainly focused the association of pulmonary vascular pressures with risk of mortality and morbidity on adult rheumatic or degenerative mitral insufficiency; however, knowledge is still lacking regarding pediatric population with congenital mitral insufficiency. The investigator wil assess the relationship between baseline sPAP and risk of operative morbidity and mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • evidence of normal or preserved left ventricular systolic function (defined as left ventricular ejection fraction [LVEF] >50%);
  • native mitral regurgitation of grade moderate or greater;
  • with or without systemic-to-pulmonary shunting necessitating concomitant surgical repairs, regardless of pulmonary arterial pressure or pulmonary artery wedge pressure.

排除标准

  • functional single ventricle;
  • rheumatic mitral diseases;
  • Eisenmenger syndrome;
  • aortopathy, transposition of the great arteries, obstructions of ventricular outflow tract, malignant arrhythmias, cardiomyopathy, microbiological identification of infective endocarditis;
  • a history of pericardiotomy or intervention therapy.

结局指标

主要结局

Recurrence-free survival

时间窗: Postoperatively; until five years after initial operation

recurrence-free survival is defined as free of more than moderate mitral valve regurgitation

次要结局

  • Postoperative complications(Postoperatively, until one month after initial operation)

研究者

发起方
Hong Liu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hong Liu

Clinical Investigator

Nanjing Medical University

研究点 (1)

Loading locations...

相似试验