STUCK VALVE REGISTRY TRIAL
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
Dr Nandhakumar Vasu
The Madras Medical Mission
