NCT07148973已完成不适用
Outcomes for Patients With Ascending Aortic Dilation Who Underwent Transcatheter Aortic Valve Replacement in a Chinese Population
zjq1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- All-Cause Mortality
研究概览
简要总结
The present study was designed to evaluate the safety of TAVR with a preoperative ascending aortic (AA) diameter ≥ 40 mm. This study also aimed to explore the procedural outcomes and clinical prognoses of patients with AAD combined compared to those of patients without AAD combined who underwent TAVR.
Between January 2019 and July 2021, a total of 186 patients who were diagnosed at a single centre with severe AS underwent the TAVR procedure using a self-expanding valve. The AA diameter was evaluated via 3-dimensional (3D) multidetector computed tomography (MDCT) before TAVR. AAD was defined as a value of AAD ≥ 40 mm.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 93 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) severe AS patients diagnosed on the recommendation of the European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines (aortic valve area ≤ 1.0 cm²/aortic valve index ≤ 0.6 cm²/m²/peak aortic velocity (Vmax)≥4.0 m/s); (2) patients at intermediate- to high-risk surgical risk or a Society of Thoracic Surgeons risk (STS) score > 4; (4) patients whose anatomy was evaluated by 3-dimensional (3D) multidetector computed tomography (MDCT) appropriate for TAVR; and (4) patients with severe AS with typical symptoms.
排除标准
- •(1) patients with active endocarditis, acute aortic dissection, or acute myocardial infarction; (2) patients with expectations of life< 1 year; and (3) patients with inappropriate anatomy evaluated by 3D MDCT.
结局指标
主要结局
All-Cause Mortality
时间窗: 6 month
Mortality
时间窗: 6 month
次要结局
未报告次要终点
研究者
zjq
Investigator
Affiliated Zhongshan Hospital of Dalian University
研究点 (1)
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