Department of Cardiology, West China Hospital, Sichuan University, Chengdu, People's Republic of China.
Department of Medical Affairs, Venus Medtech (Hangzhou) Inc, Hangzhou, China.
BMJ Open. 2023 Dec 18;13(12):e078061. doi: 10.1136/bmjopen-2023-078061.
Decisions regarding the optimal timing of intervention for asymptomatic aortic stenosis (AS) are controversial. The study aims to identify potential risk factors for asymptomatic patients with severe AS that are associated with worse prognosis and to evaluate the benefits of early interventions for asymptomatic patients presenting with one or more additional risk factors.
This is a non-interventional, prospective, open-label, multicentre registry study across China. A total of 1000 patients will be enrolled and categorised as symptomatic or asymptomatic. The primary endpoint is the occurrence of all-cause mortality, stroke, acute myocardial infarction and heart failure-related hospitalisation at 1-year follow-up. In asymptomatic severe AS patients presenting with one or more risk factors, the occurrence rate of the primary endpoint between those who undergo transcatheter aortic valve replacement (TAVR) and those who do not will be compared. We will also compare the occurrence rate of the primary endpoint for asymptomatic severe AS patients with additional risk factors who undergo TAVR with those presenting with symptoms. This study is believed to provide additional evidence to help clinicians identify and refer severe AS patients who are asymptomatic but present with additional risk factors for early intervention of TAVR.
The study protocol has been approved by the local ethics committee of each participating site: West China Hospital, Sichuan University; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Second Hospital of Hebei Medical University; Tianjin Chest Hospital; and First Affiliated Hospital of Nanchang University. All participants will provide written informed consent. Study results will be published through academic conferences and peer-reviewed journals.
This study was registered at the Chinese Clinical Trial Registry (https:// www.chictr.org.cn), with the registration number ChiCTR2200064853.
关于无症状主动脉瓣狭窄（AS）的最佳干预时机的决策存在争议。本研究旨在确定与严重 AS 无症状患者预后较差相关的潜在危险因素，并评估对有一个或多个附加危险因素的无症状患者进行早期干预的获益。
这是一项在中国进行的非干预性、前瞻性、开放性、多中心登记研究。将纳入 1000 名患者，并分为有症状或无症状。主要终点是 1 年随访时全因死亡率、卒中和急性心肌梗死以及心力衰竭相关住院的发生。在有一个或多个危险因素的无症状严重 AS 患者中，比较行经导管主动脉瓣置换术（TAVR）和未行 TAVR 的患者发生主要终点的发生率。我们还将比较有附加危险因素的无症状严重 AS 患者行 TAVR 与出现症状的患者发生主要终点的发生率。本研究有望提供额外的证据，帮助临床医生识别和转介无症状但存在附加危险因素的严重 AS 患者进行 TAVR 的早期干预。
该研究方案已获得每个参与地点的当地伦理委员会的批准：四川大学华西医院；浙江大学医学院附属邵逸夫医院；河北医科大学第二医院；天津市胸科医院；南昌大学第一附属医院。所有参与者将提供书面知情同意书。研究结果将通过学术会议和同行评议期刊发表。
本研究在中国临床试验注册中心（https://www.chictr.org.cn）注册，注册号 ChiCTR2200064853。
