| Institution: | 1. University of California-Davis, Medical Center, Davis, California, USA;2. Abbott Northwestern Hospital, Minneapolis, Minnesota, USA;3. Marcus Valve Center, Piedmont Heart Institute, Atlanta, Georgia, USA;4. Stanford University Medical Center, Palo Alto, California, USA;5. Ascension Healthcare, Wichita, Kansas, USA;6. Henry Ford Hospital, Detroit, Michigan, USA;7. St. Vincent Hospital, Indianapolis, Indiana, USA;8. West Virginia University, Morgantown, West Virginia, USA;9. Mayo Clinic, Rochester, Minnesota, USA;10. University of Michigan Medical Center, Ann Arbor, Michigan, USA |
| Abstract: | 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. |
