MedStar Cardiovascular Research Network Launches Mitral Valve Screening Survey Registry

August 16, 2021—MedStar Cardiovascular Research Network announced the launch of the Mitral Valve Screening Survey (MVSS) registry. The first patient was enrolled in the MVSS registry at MedStar Washington Hospital Center in Washington, DC, on August 6, 2021.

Ron Waksman, MD, is Principal Investigator of the MVSS registry. Dr. Waksman is Professor of Medicine at Georgetown University in Washington, DC, and Associate Director of Cardiology and Director of Cardiovascular Research and Advanced Education at the MedStar Heart & Vascular Institute.

The MVSS registry is an investigator-initiated prospective, multicenter registry that will collect baseline demographics, patients’ natural history and clinical profile, anatomical/imaging characteristics, and clinical outcomes of up to 1,000 patients who fail screening for transcatheter mitral valve intervention (TMVI). The registry is sponsored by the MedStar Health Research Institute and supported in part by a grant from Medtronic.

The primary study endpoint of the MVSS registry is mortality at 30 days. 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 patients will include a baseline assessment (demographics, clinical characteristics, frailty, echocardiography, and CT imaging) and scheduled follow-up assessments, advised the MedStar Cardiovascular Research Network.

The announcement noted that, many patients referred for TMVI do not pass stringent screening criteria for enrollment into clinical trials for the procedures’ 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.

“We are pleased to announce our first enrollment into the MVSS, which aims to study the natural history of patients who were candidates for TMVI but failed the screening process,” commented Dr. Waksman in the announcement. “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.”

Dr. Waksman stated further, “A multi-institutional heart team from the United States and Europe will serve as a steering committee and will monitor the study outcome and conduct.”