A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Mortality
研究概览
简要总结
A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
详细描述
1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
- •Patient has senile degenerative aortic valve stenosis
- •Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
- •Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.
排除标准
- •Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
- •Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
- •Patient has severe aortic valve regurgitation.
- •Patient has severe mitral valve regurgitation.
- •Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
- •Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
结局指标
主要结局
Mortality
时间窗: 1 year
Number of Deaths
次要结局
- Device Success(30 days)
- Hospitalization Length of Stay(7 days)