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临床试验/NCT04518709
NCT04518709Unknown不适用

The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children

National Cardiovascular Center Harapan Kita Hospital Indonesia0 个研究点目标入组 58 人开始时间: 2020年8月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
58
主要终点
Change of NT-proBNP at 3 months after surgery

研究概览

简要总结

The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases). Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process. Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure. Besides, the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation, after repairing with ring annuloplasty, there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big. No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively. Therefore, by analyzing postoperative mitral valve structural abnormalities with conventional techniques, an additional posterior mitral valve elevation technique was designed to increase the area of coaptation between two leaves of the mitral valve so that the incidence of postoperative regurgitation lesions can be reduced.

详细描述

The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions (49% of the total cases). Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process. Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure. Besides, the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation, after repairing with ring annuloplasty, there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big. No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively.

Therefore, by analyzing postoperative mitral valve structural abnormalities with conventional techniques, an additional posterior mitral valve elevation technique was designed. The posterior annulus elevation technique is a technique that is carried by lifting the posterior mitral annulus towards the cranial so that the posterior mitral leaflet can meet perfectly with the anterior mitral leaflet indicated by a larger coaptation area. This technique can be applied after repair with conventional techniques done optimally to reduce the possibility of postoperative residual lesions.

The hypothesis in this study is that pediatric patients with mitral regurgitation who undergo mitral valve repair surgery with posterior annulus elevation techniques can reduce residual mitral regurgitation, improve clinical and metabolic outcomes of postoperative heart failure, and reduce the risk of postoperative hemolysis.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with mitral regurgitation heart disease.
  • •Patients with an age range of 1 day - 18 years
  • •Patients with mitral regurgitation heart disease with atrial septal defects
  • •Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)

排除标准

  • •Patients refuse to participate in the study.
  • •Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
  • •Reoperation mitral valve surgery.
  • •History of abnormalities in the central nervous system / preoperative stroke.
  • •Patients with severe pulmonary hypertension
  • •Patients with small left ventricles (LV smallish)
  • •History of pulmonary resuscitation (CPR) before surgery.
  • •Dropout Criteria
  • •The patient fails to complete the entire examination procedure.
  • •Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
  • •Using extracorporeal life support (ECMO) device after surgery.
  • •History of intra-operative CPR.

研究组 & 干预措施

Posterior Annulus Elevation Technique Group

Experimental

In patients who were determined in the treatment group, after the conventional procedure for mitral valve repair was completed, a posterior mitral valve elevation technique will be performed.

干预措施: Posterior Mitral Annulus Elevation Technique (Procedure)

Without Posterior Annulus Elevation Technique Group

Placebo Comparator

No additional procedure will be done after conventional mitral valve repair

干预措施: Conventional Mitral Valve Repair (Procedure)

结局指标

主要结局

Change of NT-proBNP at 3 months after surgery

时间窗: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling.

Change of Haptoglobin at 3 months after surgery

时间窗: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery

Residual mitral valve regurgitation

时间窗: 5 days after surgery

Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography

Mitral valve coaptation area

时间窗: Intraoperative

Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography

Change of Lactate dehydrogenase at 3 months after surgery

时间窗: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery

Lactate dehydrogenase level that indicated the presence of intravascular hemolysis is measured after the surgery

次要结局

未报告次要终点

研究者

发起方
National Cardiovascular Center Harapan Kita Hospital Indonesia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Budi Rahmat

Chief of Pediatric & Congenital Heart Surgery Division

National Cardiovascular Center Harapan Kita Hospital Indonesia

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