CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Hemodynamic Performance
研究概览
简要总结
The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.
详细描述
The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with a CryoValve SGAV as an aortic valve replacement.
- •Patients who were ≤ 21 years of age at the time of implant.
排除标准
- •Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.
- •Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.
- •Patients that were ≥ 22 years of age at the time of implant.
结局指标
主要结局
Hemodynamic Performance
时间窗: From Implant until Study Enrollment (on average, 7 years)
Peak Aortic Gradient (or Peak Velocity), Mean Aortic Gradient, Aortic Insufficiency, Effective Orifice Area
Number of Adverse Events as a Measure of Safety
时间窗: From Implant until Study Enrollment (on average, 7 years)
Safety parameters will follow the guidelines for reporting morbidity and mortality after cardiac valvular operations as established by The American Association for Thoracic Surgery and The Society of Thoracic Surgeons. Evaluation of the following adverse events: * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis (all and valvular) * Thrombosis * Thromboembolism * Non-structural dysfunction * Perivalvular leak (all and major) * Bleeding (all and major) * Hemolysis * Calcification * Conduit failure
次要结局
未报告次要终点