NCT04754217招募中不适用
Valved Graft Post-Market Clinical Follow-up Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 48
- 主要终点
- annualized event rate of all-cause mortality
研究概览
简要总结
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
排除标准
- •anticoagulation therapy intolerant
- •active endocarditis
- •anatomical or medical, surgical, psychological or social contraindications
研究组 & 干预措施
Group 2
CAVGJ
干预措施: CAVGJ (Device)
Group 1
VAVGJ
干预措施: VAVGJ (Device)
结局指标
主要结局
annualized event rate of all-cause mortality
时间窗: 5 Years
Primary Safety Endpoint
annualized event rate of reintervention
时间窗: 5 Years
Primary Effectiveness Endpoint
次要结局
未报告次要终点
研究者
研究点 (48)
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