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临床试验/NCT05836532
NCT05836532已完成不适用

Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 110 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
110
试验地点
1
主要终点
MR 2+ or more recurrency

研究概览

简要总结

Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery.

Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed.

The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Mitral regurgitation with degenerative etiology
  • Mitral pathology exclusively dependent on P2
  • Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique.

排除标准

  • Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

结局指标

主要结局

MR 2+ or more recurrency

时间窗: through study completion, a minimum of 2 years

次要结局

  • Reintervention(through study completion, a minimum of 2 years)

研究者

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

Michele De Bonis

Chief od Cardiac Surgery of Advanced and Research Therapies

Ospedale San Raffaele

研究点 (1)

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