CryoValve SG Pulmonary Human Heart Valve Post Clearance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Safety Assessment
研究概览
简要总结
The purpose of this study is to collect long-term follow-up data of the CryoValve SG Pulmonary Human Heart Valve.
详细描述
The CryoValve SG pulmonary human heart valve is recovered from deceased human donors, treated with the SynerGraft® 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety Assessment
时间窗: Since Implant of the Valve to a Maximum of 13.0 years
Evaluation of the following adverse events * Mortality (all cause and valve-related) * Reoperation/reintervention * Explant * Endocarditis * Structural valve deterioration (defined as \>40 mmHg peak pulmonary gradient or \>30 mmHg mean pulmonary gradient or moderately severe to severe pulmonary insufficiency) * Thrombosis * Thromboembolism (pulmonary embolism) * Non-structural dysfunction * Perivalvular leak * Bleeding * Hemolysis * Calcification
Hemodynamic Performance
时间窗: Most Recent Follow-up (average of 4 to 6 years post implant)
Pulmonary Insufficiency Grade
次要结局
未报告次要终点