PRospective Evaluation Complementing Investigation With Acurate Neo Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Device success of implantation
研究概览
简要总结
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
详细描述
The study collects real-world data of patients who were treated with the Acurate Neo TAVI System and evaluates early and midterm clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •≥18 years.
- •Severe aortic stenosis with indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.
- •Has signed the Patient Informed Consent Form.
排除标准
- •Severe aortic stenosis without indication of implantation of aortic valve prosthesis in which an Acurate Neo device is implanted according to the indications for use.
结局指标
主要结局
Device success of implantation
时间窗: 7 days
Proportion of patients with device success of implantation defined as: * absence of procedural mortality AND * correct positioning of a single prosthetic heart valve into the proper anatomical location AND * no prosthesis - patient mismatch AND * mean aortic valve gradient \<20 mmHg, AND * no moderate or severe prosthetic valve regurgitation
Cardiovascular death
时间窗: 30 days post-index procedure
Cumulative incidence of a combination of all cause Cardiovascular death
次要结局
- Assessment of early safety(30 days)
- Assessment of time-related valve safety(30 days)
- Assesment of NYHA (New York Heart Association ) classification(7 days, 30 days, 12 month)
- Assessment of mean aortic gradient post-implantation(up to one year)
- Death during the hospitalization of the patient(date of procedure till date of estimated discharge, assessed up to two weeks)