Artificial Valve Endocarditis Reduction Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 807
- 试验地点
- 24
- 主要终点
- Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
研究概览
简要总结
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
详细描述
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this study are:
- Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal incidence of PVE when compared to those receiving the conventional cuff.
- Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient requires an isolated mitral, isolated aortic, or double (aortic and mitral) valve replacement
- •The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series valve(s) with either the conventional cuff or the cuff with Silzone coating
- •The patient (or legal guardian) has signed a study-specific consent form agreeing to the randomization, data collection, and follow-up requirements
排除标准
- •The patient has a medical condition which contraindicates implantation of the SJM Masters Series with Silzone coating
- •The patient already has a prosthetic valve other than the valve being replaced at this time
- •The patient requires a tricuspid valve replacement
研究组 & 干预措施
St. Jude Medical (SJM) Conventional
St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff
干预措施: Artificial Mechanical Heart Valve (Device)
St. Jude Medical (SJM) Silzone
St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating
干预措施: Artificial Mechanical Heart Valve (Device)
结局指标
主要结局
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
时间窗: 1 year
Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group.
次要结局
未报告次要终点