POST MARKET CLINICAL FOLLOW UP STUDY OF CARDIAMED PROSTHETIC HEART VALVE
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The objective of this study is to assess continued safety and effectiveness of the
研究概览
简要总结
Rheumatic heart disease is a growing concern in India, which causes single or multiple valve stenosis and regurgitation.
Patients eventually undergo open heart surgery for valve replacement using mechanical bileaflet prosthetic valve.This study is to study the long term effects of prosthetic valve in terms of anticoagulation doses and post op ECHO findings and NYHA class.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •patients undergoing isolated valvular surgery.
排除标准
- •Patients who have undergone any other type of open heart surgery along with valve will be excluded.
- •also ,if patients have died during this span post surgery are excluded.
结局指标
主要结局
The objective of this study is to assess continued safety and effectiveness of the
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
CardiaMed Prosthetic Heart Valve.
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
The ACCEPTANCE HYPOTHESIS is that the adverse events or true rate of complications
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
associated with the CardiaMed Prosthetic heart Valves are less than two times the
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
Objective Performance Criteria (OPCs) specified in the international standard ISO
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
5840-2:2021.
时间窗: The outcome is to look into the results post surgery at the end of 1 month.
次要结局
未报告次要终点
研究者
Dr Uday Jadhav
Seth GS Medical College and KEM Hospital