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临床试验/NCT04299334
NCT04299334Unknown1 期

A Novel Adjustable Neochordae Technique in Mitral Valve Repair

National Heart Institute, Egypt2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
30
试验地点
2
主要终点
competency of mitral valve repair

研究概览

简要总结

Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.

In our novel technique,Investigators are not depending either on the preoperative investigations or intraoperative reference chordae in the adjustment of the optimal length of the neochordae, however, Researchers depend on the personal adjustment of the chordal length to the prolapsed scallop.

详细描述

Mitral regurgitation (prolapse) and mitral stenosis are examples of diseases that affect the mitral valve. In mitral regurgitation, the leaflets do not close tightly and sway up and down allowing the blood to flow backward from the left ventricle into the left atrium. on the other hand, the mitral stenosis is caused by folding of thick leaflets of the valve which fuses together leading to low blood flow from the left atrium into the left ventricle and these cases are excluded from our trial. In mitral regurgitation, Surgeons prefer the mitral valve repair over the mitral valve replacement, But still, there are a lot of challenges towards this technique.

For decades, Surgeons used a lot of techniques to determine the length of neochordae includes that:

Determination of neochordal length by transoesophageal echocardiography or by using a landmark as a direct measurement. Previously, the surgeon applying the fixed loop length technique by using a custom-made caliper, and on the distance between the edge of a non-prolapsing segment and the tip of the papillary muscle (usually P1) to define the correct loop length. There are different types of papillary muscle and chordae as regards the shape, morphology, and length. So this reference distance is not fixed.

Adjusting neochordal length according to valve function. Length is chosen when the regurgitation is completely removed. Existing of a large number of neochordae will make this process more complex for the surgeon to decide.

Mitral valve (MV) repair has turned into a preferable option for surgeons over the MV replacement. Since the 1960s, Surgeons use this technique for more efficiency and durability. On the other hand, the proper determination of length and placement of artificial neochordae is still a challenge beyond this technique. These challenges are still a vital area for research and debate between surgeons and researchers.

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prolapsed or ruptured chordae
  • Either degenerative or ischemic

排除标准

  • Patient with redo Mitral Valve surgery
  • Patient with severe rheumatic mitral stenosis (MS).

结局指标

主要结局

competency of mitral valve repair

时间窗: 6 months follow up

by using the transthoracic echocardiography or the trans-esophageal echo to measure the mitral valve competency and the degree of mitral regurge.

次要结局

未报告次要终点

研究者

发起方
National Heart Institute, Egypt
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Yosry Mahmoud Thakeb

Principal Investigator

National Heart Institute, Egypt

研究点 (2)

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