Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Rate of ascending aortic dilatation
研究概览
简要总结
The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are:
- whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation;
- the determinants of postoperative ascending aortic dilatation.
详细描述
Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.
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
- •Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less;
- •Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more;
- •High risk of surgical aortic valve replacement;
- •Suitability for a transfemoral vascular access.
排除标准
- •Dominant aortic regurgitation;
- •History of surgical or transcatheter aortic valve replacement;
- •History of aortic surgery;
- •Connective tissue disorders.
结局指标
主要结局
Rate of ascending aortic dilatation
时间窗: 1-year and 2-year
The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
次要结局
- Rate of all-cause mortality(1-year and 2-year)
- Rate of adverse aortic events(1-year and 2-year)