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临床试验/NCT06153563
NCT06153563招募中不适用

Evaluation of the Elasticity of the Mitral Valve Chordae by Uniaxial Traction in the Context of Mitral Valve Regurgitation With a Comparison of the Results: Mitral Valve Prolapse vs Restriction of Mitral Valve Movement

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Maximum value of Young's modulus

研究概览

简要总结

There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

详细描述

The prospective study will be conducted on 20 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

The harvested tissue will not be frozen and will kept in natural conditions as close as possible.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients programmed for mitral valve replacement who have more than 45 years old

排除标准

  • Patients with mitral calcification
  • Mitral valve rheumatic disease
  • Mitral valve infections
  • Redo surgery on the mitral valve

结局指标

主要结局

Maximum value of Young's modulus

时间窗: Hour 1

Comparison of elasticity difference between the two groups

次要结局

  • First histological evaluation(Hour 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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