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临床试验/CTRI/2024/05/067331
CTRI/2024/05/067331尚未招募不适用

STUCK VALVE REGISTRY TRIAL

The Madras Medical Mission1 个研究点 分布在 1 个国家目标入组 1,204 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,204
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

Mechanical heart valves are recommended in mitral valve disease patients aged <65 years or aortic valve disease patients aged <60 years with a reasonable life expectancy and no contraindications to long-term anticoagulation.1 This recommendation was made because of the durability of the mechanical prosthesis over bioprosthesis. However, the durability of the mechanical valve is often challenged by obstructive thrombus as early as the first year. Redo surgery or fibrinolysis in high-risk surgery patients is the currently available evidence-based treatment.1Percutaneous transcatheter release of stuck valve (PETROS) with cerebral embolic protection for left sided mechanical valves is the upcoming therapeutic modality.2,3 The mechanical heart valve thrombosis incidence ranges from 0.1% to 5.7%.4 Redo cardiac surgery often ends in a new valve replacement with a bioprosthetic valve, though few reports of thrombus removal or pannus removal are available in the literature.4 Ultra-slow infusion of fibrin-specific fibrinolytic agent has shown promise over bolus fibrinolysis. Yet, the failure to release the stuck leaflets or embolic stroke and systemic embolism were seen as dreadful complications.5In this study we determine the short-term and long-term outcomes of these three treatment modalities namely surgery, PETROS and Fibrinolysis.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • The patients who underwent repeat surgery, fibrinolysis or PETROS for stuck valve from First January 2019 till the CTRI registration of this registry will be included retrospectively.
  • From the completion of CTRI registration the participants will be included prospectively till 2029.

排除标准

  • Not willing to participate.

结局指标

主要结局

All-cause mortality

时间窗: 30days

次要结局

  • All-cause mortality(one-year)

研究者

申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Nandhakumar Vasu

The Madras Medical Mission

研究点 (1)

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