The Clinical Profile and Natural History of Patients Who Fail Screening for Transcatheter Mitral Valve Replacement: Rationale and Design of the Prospective Multicenter Mitral Valve Screening Survey (MVSS).

Mitral valve disease is insidious and associated with a decreased quality of life and survival over time. Despite surgery being the standard of care, many patients are at prohibitive surgical risk. Furthermore, a substantial proportion of patients with symptomatic mitral valve disease fail stringent screening criteria for transcatheter mitral valve replacement (TMVR). The natural history of patients who fail screening is not well-characterized, and data are limited on the reasons for screen failure in this population. The Mitral Valve Screening Survey (MVSS) seeks to detail the clinical profile and natural history of patients who fail screening for TMVR. The MVSS is a prospective, multicenter registry enrolling up to 1000 consecutive subjects who, after screening for TMVR, are deemed not to be candidates. Subjects will be followed for 30 days after failing screening for TMVR and annually for up to 5 years with clinical evaluations. The primary study endpoint of the MVSS registry is all-cause mortality at 1 year. Additional secondary endpoints include all-cause mortality, hospitalizations, subsequent mitral valve intervention (transcatheter or surgical), reason for screen failure, and quality-of-life assessments at 30 days and annually up to 5 years of follow-up. The MVSS registry is the first prospective multicenter study to characterize the clinical and anatomical profile of patients who fail screening for TMVR while providing longitudinal clarification on the natural history and outcomes of these patients. CLINICAL TRIAL REGISTRATION: Mitral Valve Screening Survey (MVSS), https://clinicaltrials.gov/ct2/show/NCT04736667, NCT04736667.