A Retrospective, Single Center, Observational Study to Evaluate Long-term survival of patients with valvular heart who underwent prosthetic valve replacement and were managed with Nicoumalone (Acenocoumarol) and tissue valve outcomes operated by a single surgeon
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 718
- 试验地点
- 1
- 主要终点
- To measure the overall survival of patients with VHD who underwent prosthetic valve replacement and managed with INR-based dose titration of Nicoumalone (Acenocoumarol)
研究概览
简要总结
Currently in India, there is paucity of data on long-term survival of patients undergoing prosthetic valve replacement. Long-term data will provide the importance of addressing proper anticoagulation techniques to minimize postoperative thrombotic complications while maintaining acceptable levels of risk related to bleeding . The objective of this study proposed design is to assess the long term outcomes in patients with valvular heart disease who had undergone prosthetic valve replacement with adequate monitoring of the INR and dose titration of Acenocoumarol.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient who underwent prosthetic valve replacement since Jan 1971 2.Patient who were managed by Nicoumalone (Acenocoumarol) after the prosthetic valve replacement and whose dose titration was done based on the INR monitoring 3.Patient with no prior history of MACCE- Stroke, MI, and major bleeding.
排除标准
- •1.Patient who underwent Cardiac Surgery other than Prosthetic Valve Replacement, eg.
- •Coronary Artery Bypass Graft Surgery(CABG) etc.
- •2.Patient who underwent prosthetic valve replacement procedure before Jan 1971.
结局指标
主要结局
To measure the overall survival of patients with VHD who underwent prosthetic valve replacement and managed with INR-based dose titration of Nicoumalone (Acenocoumarol)
时间窗: At the end of the follow-up
次要结局
- 1.To assess the incidence of major complications associated with the disease like major adverse cardiac and cerebrovascular events (MACCE e.g., Stroke, MI) and major bleeding(2.To assess clinical outcome after surgery for Atrial Fibrillation with Mitral Valve pathology)