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临床试验/NCT05774808
NCT05774808已完成不适用

Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitation

Michele De Bonis1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2022年2月2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
154
试验地点
1
主要终点
Mortality for cardiac causes

研究概览

简要总结

Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case.

When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team.

To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients.

The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.

研究设计

研究类型
Observational
观察模型
Case Control
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 with severe aortic regurgitation (AR) AND moderate mitral regurgitation (MR).
  • Patients underwent isolated aortic valve surgery (Study Group) or concomitant mitral valve surgery (Control Group) and
  • Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from January 2004 to January 2019

排除标准

  • Patient with more than moderate MR

结局指标

主要结局

Mortality for cardiac causes

时间窗: Through study completion, an average of 7 years

次要结局

  • Reintervention for severe AR recurrency(Through study completion, an average of 7 years)
  • Severe AR recurrency(Through study completion, an average of 7 years)
  • All causes mortality(Through study completion, an average of 7 years)
  • Reintervention for severe MR(Through study completion, an average of 7 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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