跳至主要内容
临床试验/NCT05774769
NCT05774769已完成不适用

Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年10月9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
125
试验地点
1
主要终点
Mortality

研究概览

简要总结

Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.

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

  • Adult patients;
  • Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
  • Patients operated on with median sternotomy or left minithoracotomy;
  • Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
  • Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.

排除标准

  • Patients underwent a mitral valve replacement

结局指标

主要结局

Mortality

时间窗: Through study completion, an average of 14,5 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)

Loading locations...

相似试验

Commissural Closure to Treat Severe Mitral... | 临床试验