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临床试验/NCT05936125
NCT05936125尚未招募不适用

Short Term Outcomes Of Tricuspid Valve Annuloplasty Using A Flexible Band

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Tricuspid valve regurgitation

研究概览

简要总结

Functional tricuspid regurgitation (FTR) remains a common finding in patients with left-sided valvular heart diseases especially mitral valve regurgitation or stenosis. It is mainly caused by dilatation and flattening of the tricuspid valve (TV) annulus as a result of right ventricular (RV) enlargement and is inevitably affected by the RV function. Multiple studies support the better outcome of using rigid ring annuloplasty over suture repair for treating FTR in concern with the durability and freedom from residual regurgitation. These studies refer the superiority of rigid ring annloplasty to the three-dimensional configuration achieved by such rings which matches the normal tricuspid annulus and, at the same time, to the rigid support of the annulus. On the other hand, other studies support the use of flexible prosthetic bands like Dacron or polytetrafluroethilin (PTFE), especially over suture techniques, due to their easy applicability and availability with good postoperative results. Therefore, suture annyloplasty became nowadays less convenient for FTR repair since both flexible bands and rigid rings appeared to offer good midterm outcomes in recent meta-analysis studies. However, the ideal annuloplasty method for repairing FTR is still debatable between the three-dimensional (3D) rigid rings versus flexible prosthetic bands. In this retrospective comparative study, we share our experience with flexible fashioned bands in FTR.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients presented at Assiut University Hospital with tricuspid valve regurgitation

排除标准

  • Age less than 18 years old.
  • Tricuspid valve stenosis.
  • Organic tricuspid valve disease.
  • Infective endocarditis on tricuspid valve.

结局指标

主要结局

Tricuspid valve regurgitation

时间窗: 1 year post operative

Using Echocardiography to asset tricuspid valve regurgitation

次要结局

  • Tricuspid Annular Plane Systolic Excursion (TAPSE)(1 year post operative)

研究者

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

Mahmoud Sayed

M.D. Mahmoud Kamel Mohamed Sayed

Assiut University

研究点 (2)

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