跳至主要内容
临床试验/NCT03038204
NCT03038204Unknown不适用

The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation

The Federal Centre of Cardiovascular Surgery, Russia0 个研究点目标入组 100 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Mitral regurgitation severity (1,2 or 3)

研究概览

简要总结

Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt.

详细描述

Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction. Among several surgical procedures, mitral ring annuloplasty has been the method of choice for a considerable period. However, mitral regurgitation recurrence after surgery has a reported occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory outcomes. The pathophysiology of IMR is complex and results from the imbalance between closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular chamber, and displacement of papillary muscles in apical and lateral direction increase the tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial contractility decrease closing forces, which lead to impaired leaflet coaptation and appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an integrated approach affecting all units of the pathogenesis of MR recurrence.

Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these procedures is the papillary muscles approximation. However, the safety and the positive impact of this method are still in doubt. This study is conducted to identify the positive qualities and safety of this technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Ischemic cardiomyopathy,
  • Ischemic mitral regurgitation.

排除标准

  • Degenerative mitral valve disease,
  • Unstable angina,
  • Recent myocardial infarction (< 6 months),
  • Papillary muscles rupture,
  • Severe right ventricular dysfunction,
  • Multiple organ failures,
  • Concomitant left ventricular reconstruction,
  • Aortic valve procedures.

结局指标

主要结局

Mitral regurgitation severity (1,2 or 3)

时间窗: 1 year

Mitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.

次要结局

  • Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)(1 year)
  • End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)(1 year)
  • Ejection fraction (%)(1 year)
  • Tenting area (mm^2)(1 year)

研究者

发起方
The Federal Centre of Cardiovascular Surgery, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikulyak Artur

Principal Investigator, Cardiovascular surgeon

The Federal Centre of Cardiovascular Surgery, Russia

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