跳至主要内容
临床试验/NCT07019935
NCT07019935招募中不适用

Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER Study)

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Afterload mismatch

研究概览

简要总结

Mitral regurgitation (MR) is one of the most common valvular heart diseases in China, causing heart failure. Patients with moderate to severe MR have a very poor clinical prognosis if no intervention is performed. When symptoms are still poorly controlled after guideline-directed medical therapy (GDMT) or when surgical intervention is not suitable, transcatheter mitral valve edge-to-edge repair (TEER) can improve the patient's quality of life and reduce the hospitalization rate and mortality rate. However, some patients develop into afterload mismatch (AM) after TEER, persistent adverse ventricular remodeling, and a high mortality rate, which limits the surgical benefits of TEER surgery in these MR patients. Therefore, how to scientifically predict AM and intervene as early as possible has become a research hotspot for optimizing the postoperative management of TEER patients. Afterload Mismatch Predictive modLE for Transcatheter Edge-to-Edge Repair (AMPLE-TEER) study is a prospective cohort study including adult patients undergoing TEER during hospitalization. We aim to evaluate whether the patients develop into AM after TEER, evaluate the prognostic risk factors of AM and construct a prognostic clinical model to guide clinical decision-making.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization.
  • Aged over 18 yrs.

排除标准

  • Patients unable to provide written consent.

结局指标

主要结局

Afterload mismatch

时间窗: Through study completion, an average of 5 years

The increase in the patient's left ventricular end-diastolic volume index (LVEDVi) after transcatheter mitral valve edge-to-edge repair (TEER) was 10% or more compared with before (dLVEDVi ≥10%).

次要结局

未报告次要终点

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao-dong Zhuang

Dr.

Sun Yat-sen University

研究点 (1)

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