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临床试验/NCT05850026
NCT05850026已完成不适用

Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 26 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
26
试验地点
1
主要终点
Survival time after intervention

研究概览

简要总结

Septal myectomy is performed in selected cases to treat patients with hypertrophic obstructive cardiomyopathy (HOCM). The mechanism that causes obstruction involves both the outflow tract itself and the mitral apparatus, with the appearance of mitral regurgitation (MR) by SAM (Systolic Anterior Motion).

When the interventricular septum is not particularly thick, isolated myectomy may not be sufficient to eliminate the SAM; in these cases the concomitant treatment of the mitral valve is considered. Different approaches have been proposed: mitral replacement with prosthesis, plication or lengthening of the anterior leaflet or the edge-to-edge (EE) technique.

In addition, a small proportion of patients with HOCM may have MR from organic valve abnormalities, requiring specific treatment.

Currently, there are few studies in the literature aimed at determining the role of EE in the context of HOCM; most of these studies are characterized by short follow-up or by the scarcity of echocardiographic data.

The aim of the present study is to evaluate the long-term outcomes of EE associated with septal myectomy in patients with CMIO, both from a clinical point of view and by reporting echocardiographic data.

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

  • diagnosis of HOCM with indication for surgery,
  • patients operated on from 2000 to 2017
  • contextual diagnosis of MR needing reparative surgical treatment
  • age ≥ 18 years

排除标准

  • hypertophic left ventricle due to other causes (aortic stenosis, arterial hypertension)

结局指标

主要结局

Survival time after intervention

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

freedom from reintervention

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

次要结局

未报告次要终点

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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