Randomized Trials Are Needed for Transcatheter Mitral Valve Replacement

Jason H. Rogers, Paul Sorajja, Vinod H. Thourani, Rahul Prakash Sharma, Bassem Chehab, Jennifer Cowger, David Heimansohn, Vinay Badhwar, Mayra Guerrero, Gorav Ailawadi

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)2039-2046
Number of pages8
JournalJACC: Cardiovascular Interventions
Issue number18
StatePublished - Sep 27 2021


  • mitral regurgitation
  • randomized trial
  • transcatheter edge-to-edge repair
  • transcatheter mitral valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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