Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 51
- 主要终点
- Disabling Stroke
研究概览
简要总结
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
干预措施: SAPIEN 3 THV (Device)
TAVR (with SAPIEN 3 THV) and OHFT
Transcatheter heart valve and Optimal Heart Failure Therapy
干预措施: Optimal Heart Failure Therapy (Biological)
OHFT
Optimal Heart Failure Therapy
干预措施: Optimal Heart Failure Therapy (Biological)
结局指标
主要结局
Disabling Stroke
时间窗: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).
时间窗: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
Change in KCCQ relative to baseline
时间窗: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
All-Cause Death
时间窗: 12 months
Hierarchical occurrence within efficacy assessment time interval (EATI) of:
次要结局
- -All-cause death within EATI(12 month)
- MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of:(12 month)