WASHINGTON, DC (August 16, 2021) – MedStar Cardiovascular Research Network today announced that the first patient was enrolled in the Mitral Valve Screening Survey (MVSS) registry on August 6, 2021, at MedStar Washington Hospital Center. The transcatheter mitral valve intervention (TMVI) technology is designed to offer an alternative to surgical mitral valve replacement for patients who are at prohibitive risk for surgery. Despite being referred for TMVI, many patients do not pass stringent screening criteria for enrollment into clinical trials for TMVI devices for numerous reasons, including prohibitive risk, vascular access issues or patient preference not to be enrolled. The natural history of patients who screen-fail is not well characterized, and data are limited on the reasons for screen failure and the long-term outcome of these patients. The MVSS registry (NCT04736667) is an investigator initiated prospective, multicenter registry that will collect baseline demographics, anatomical/imaging characteristics and clinical outcomes of up to 1,000 patients who fail screening for TMVI. The study aims to examine the clinical profile/anatomic characteristics and, importantly, natural history of patients who fail screening for TMVI. Ron Waksman, MD, Professor of Medicine at Georgetown University and Associate Director of Cardiology and Director of Cardiovascular Research and Advanced Education at the MedStar Heart & Vascular Institute, is the Principal Investigator. “We are pleased to announce our first enrollment into the MVSS, which aims to study the natural history of patients who were candidates for transcatheter mitral valve intervention but failed the screening process,” Dr. Waksman said. “In the absence of a control group in the pivotal studies for TMVI, this natural history study carries the control value in understanding the outcome of patients who cannot be enrolled into the study. A multi-institutional heart team from the USA and Europe will serve as a steering committee and will monitor the study outcome and conduct.” The primary study endpoint of the MVSS registry is mortality at 30 days, but patients will be followed annually for 5 years. Additional secondary endpoints include hospitalizations, mitral valve intervention (transcatheter or surgical) and quality-of-life assessments. Prospective data collection for all subjects will include a baseline assessment (demographics, clinical characteristics, frailty, echocardiography and computed tomography [CT]) and scheduled follow-up assessments. The registry is sponsored by the Medstar Health Research Institute and supported in part by a grant from Medtronic (Minneapolis, Minnesota). Image Credit: SciePro – stock.adobe.com