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临床试验/NCT06811662
NCT06811662尚未招募不适用

Outcomes of Complete Versus Partial Preservation of the Sub-valvular Apparatus in Cases of Mitral Valve Replacement

Assiut University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2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
80
试验地点
2
主要终点
To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement

研究概览

简要总结

The purpose of this study is to evaluate the outcomes of complete (preservation of both anterior and posterior leaflets) versus partial (preservation of posterior leaflet only) preservation of subvalvular apparatus in cases of mitral valve replacement

详细描述

After mitral valve replacement (MVR), sudden increases in afterload and disruption of the annular-chordal-papillary-left-ventricular wall causes left ventricular (LV) dysfunction in the early postoperative period.

patients with LV dysfunction after MVR have a significantly lower 8-year survival rate compares with patients who did not have LV dysfunction Papillary muscles play an important role in the left ventricular contraction by drawing the mitral ring toward the apex, thereby causing shortening of the long axis and spherity of the chamber contribute for better ejection of blood.

preservation of papillary muscles and chordae tendineae in MVR reduces postoperative mortality, low cardiac output syndrome and improves haemodynamic function.

Partial preservation of the mitral apparatus through preservation of the posterior leaflet (MVR-P) has been proven to significantly reduce perioperative mortality.

The importance of complete preservation of the mitral apparatus remains controversial, but it is hypothesized that complete preservation with preservation of both the anterior and posterior leaflets may contribute to superior postoperative hemodynamic function as compared to partial preservation.

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
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • - Age between 18 and 60 years
  • Rheumatic mitral disease indicated for mitral valve replacement
  • Concomitant other valve disease

排除标准

  • - Patients who have undergone previous mitral valve surgery or other heart surgery.
  • Patients with ischemic mitral disease.
  • emergency operation.
  • patients with significant comorbidities (severe pulmonary disease or end stage renal disease).

结局指标

主要结局

To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement

时间窗: anticepated 3 years

To evaluate the outcomes of complete versus partial preservation of subvalvular apparatus in mitral valve replacement regarding: * Postoperative morbidity and mortality * LV function and the change of cardiac chamber dimensions.

次要结局

未报告次要终点

研究者

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

Amr Mohamed Mamdouh Hussein

dr

Assiut University

研究点 (2)

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