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临床试验/NCT05836558
NCT05836558已完成不适用

Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2019年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
127
试验地点
1
主要终点
Mortality

研究概览

简要总结

Mitral regurgitation (MR) is a disease affecting the mitral valve that it causes a volumetric and pressure overload in the left chambers due to the leak of the unidirectionality normally guaranteed by the heart valve system.

The gold standard for severe mitral regurgitation is currently surgical mitral valve repair (PLM) using longitudinal median sternotomy to expose the heart Since the mid-1990s, the right mini-thoracotomy, ie a surgical access with cut in the 3rd or 4th intercostal space that would allow to reduce the size of the surgical site making it less traumatic and more aesthetic, addressing mainly a young target population.

Since the 2000s this method has spread more and more, expanding all over the world and spreading especially in the United States and Germany. This method has been progressively used in the treatment of the whole mitral valve surgery starting from valve repair up to prosthetic replacements.

Mitral valve repair through minimally invasive access in degenerative pathology has made it possible to obtain excellent long-term results, with low recurrence rates of regurgitation. In our center the results on the first 48 patients have been published in 2005 by Lapenna et al. Over the years this method has been adopted in thousands of patients worldwide, however the data present in the literature they stop at a follow-up of about 10 years. In 2017 De Bonis et al. of the San Raffaele Hospital have published the outcome of a particular subgroup of patients (bileaflet prolapse) treated with minimally invasive access, comparing them with as many subjects subjected to the same method of mitral repair ("edge-to-edge technique or Alfieri stitch"), obtaining superimposable long-term results (about 14 years old).

The goal of the present study is to analyze very long-lasting results in patients treated with mitral valve surgery with access in right mini-thoractotomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • patients with degenerative mitral regurgitation
  • patients treated with mitral valve repair in right minithoracotomy

排除标准

  • median sternotomy

结局指标

主要结局

Mortality

时间窗: through study completion, a minimum of 16 years

次要结局

  • Reintervention(through study completion, a minimum of 16 years)

研究者

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

Michele De Bonis

Chief of Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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