Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 23
- 主要终点
- Change in total aortic regurgitation over time.
研究概览
简要总结
The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.
详细描述
The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).
Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.
The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).
- •Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.
- •The treating physician should ensure the subject will return for all required post procedure follow-up visits.
排除标准
- •Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
结局指标
主要结局
Change in total aortic regurgitation over time.
时间窗: post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up
次要结局
- Clinical events as defined per VARC-2 consensus document (VARC-2)(Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure)
- Incidence of all-cause mortality(30 days post-index procedure)
- Functional improvement(7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure)
- Hemodynamic function improvement from baseline(7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure)
- Number of patients with adverse events assessed by VARC-2 Composite Safety(30 days post-index procedure)
- Number of patients with procedural success according to VARC II criteria(at index- Procedure)
- Number of patients with device success(7-days post-index procedure or discharge (whichever occurs first))
- Valve related dysfunction(7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure)