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临床试验/NCT04002648
NCT04002648已完成不适用

Minimally Invasive or Conventional Edge-To-Edge Repair for Severe Mitral Regurgitation Due to Bileaflet Prolapse in Barlow's Disease: Does the Surgical Approach Have an Impact on the Long-term Results?

Ospedale San Raffaele0 个研究点目标入组 208 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
208
主要终点
Cardiac Death

研究概览

简要总结

The study evaluates the long-term results of patients affected by bileaflet prolapse in Barlow's Disease, treated with edge-to-edge technique between 1997 and 2011.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

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 treated for bileaflet prolapse in Barlow's Disease between 1997 and 2011

排除标准

  • Age inferior to 18 years

结局指标

主要结局

Cardiac Death

时间窗: 12 years

The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk

Severe MR

时间窗: 12 years

The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) \>_ 3+, with death as the competing risk

次要结局

未报告次要终点

研究者

发起方
Ospedale San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele De Bonis

Principal Investigator

Ospedale San Raffaele

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