Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 107
- 试验地点
- 10
- 主要终点
- All cause mortality
研究概览
简要总结
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.
Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.
详细描述
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.
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
All cause mortality
时间窗: 30 days
the rate of all-cause mortality as measured at 30-days
次要结局
- Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.(Procedure to Discharge, 30 days and 12-months)
- Procedural Success(Procedure to 24-hours)
- Device Success(Post-procedure to Discharge.)
- VARC 2 Composite Safety(30-days)
- Functional improvement as per NYHA Functional Classification(from baseline to, discharge, 30-days and 12-months follow-up.)
- Improvement of EOA and mean Trans-prosthetic gradient(from baseline to discharge, 30- days and 12 months follow-up)
- Total Aortic Regurgitation(post-procedure, prior to discharge, at 30-days and 12-months follow-up;)