A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 22
- 主要终点
- VARC-2 Composite Safety Endpoint
研究概览
简要总结
The objective of the study is to observe the safety, efficacy and cost effectiveness of the Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
详细描述
This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial. The comparatator group will consist of subjects undergoing surgical aortic valve replacement in Cohort A of the PARTNER II Trial [NCT01314313].
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 70 years
- •STS Score > 4
- •Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate
排除标准
- •Age <70 years
- •Evidence of an acute myocardial infarction ≤ 30 days
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
- •Stroke or transient ischemic attack (TIA) within 6 months of the procedure
结局指标
主要结局
VARC-2 Composite Safety Endpoint
时间窗: 30 days
The primary endpoint is a VARC-2 Composite. It comprises of 1. All cause mortality 2. All stroke 3. Life-threatening bleeding 4. Acute kidney injury - Stage 3 (including renal replacement therapy) 5. Coronary artery obstruction requiring intervention 6. Major vascular complications 7. Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.
次要结局
- All Cause Mortality(12 months)