Transcatheter mitral valve replacement (TMVR) is a new therapy for treating symptomatic mitral regurgitation (MR) and stenosis. The proposed benefit of TMVR is the predictable, complete elimination of MR, which is less certain with transcatheter repair technologies such as TEER (transcatheter edge-to-edge repair). The potential benefit of MR elimination with TMVR needs to be rigorously evaluated against its risks which include relative procedural invasiveness, need for anticoagulation, and chronic structural valve deterioration. Randomized controlled trials (RCTs) are a powerful method for evaluating the safety and effectiveness of TMVR against current standard of care transcatheter therapies, such as TEER. RCTs not only help with the assessment of benefits and risks, but also with policies for determining operator or institutional requirements, resource utilization, and reimbursement. In this paper, the authors provide recommendations and considerations for designing pivotal RCTs for first-in-class TMVR devices.

经导管二尖瓣置换术 (TMVR) 是一种治疗症状性二尖瓣关闭不全 (MR) 和狭窄的新疗法。TMVR 的拟议好处是可预测的、完全消除 MR，这对于经导管修复技术（如 TEER（经导管边缘到边缘修复））不太确定。TMVR 消除 MR 的潜在益处需要严格评估其风险，包括相对程序侵入性、抗凝需求和慢性结构性瓣膜退化。随机对照试验 (RCT) 是评估 TMVR 相对于当前经导管治疗标准（如 TEER）的安全性和有效性的有效方法。RCT 不仅有助于评估收益和风险，还有助于确定运营商或机构要求的政策，资源利用和补偿。在本文中，作者提供了为一流的 TMVR 设备设计关键 RCT 的建议和考虑因素。