医学
临床终点
阀门更换
随机对照试验
多中心试验
外科
临床试验
射血分数
主动脉瓣
冲程(发动机)
不利影响
反流(循环)
内科学
心力衰竭
狭窄
多中心研究
工程类
机械工程
作者
Juan Zhang,Xiangquan Kong,Xiaofei Gao,Jing Chen,Xiang Chen,Bo Li,Yibing Shao,Yan Wang,Hong Jiang,Jiancheng Zhu,Jun‐Jie Zhang,Shao‐Liang Chen
标识
DOI:10.1016/j.ahj.2024.02.022
摘要
Previous studies primarily demonstrated that transfemoral transcatheter aortic valve replacement (TAVR) with self-expanding valve appeared to be a safe and feasible treatment for patients with pure native aortic regurgitation (AR). However, the routine application of transfemoral TAVR for pure AR patients lacks support from randomized trials. SEASON-AR trial is a prospective, multicenter, randomized, controlled, parallel-group, open-label trial, involving at least 20 sites in China, aiming to enroll 210 patients with pure native severe AR and high surgical risk. All enrolled patients are randomly assigned in a 1:1 fashion to undergo transfemoral TAVR with VitaFlowTM valve and receive guideline-directed medical therapy (GDMT) or to receive GDMT alone. The primary endpoint is the rate of major adverse cardiac events (MACE) at 12 months after the procedure, defined by the composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure. The major secondary endpoints encompass various measures, including procedure-related complications, device success, 6-minute walk distance, and the occurrence of each individual component of the primary endpoint. After hospital discharge, follow-up was conducted through clinical visits or telephone contact at 1, 6, and 12 months. The follow-up will continue annually until 5 years after the index procedure to assess the long-term outcomes. SEASON-AR trial is the first study designed to investigate the clinical efficacy and safety of transfemoral TAVR with a self-expanding valve in patients with pure native severe AR with inoperable or high-risk, as compared to medical treatment only.
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