EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Dr. Mary Norine “Minnow” Walsh has become Co-Principal Investigator (Co-PI) of the SOLVE CRT clinical study. The SOLVE CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical study is a prospective randomized, double blinded pivotal trial intended to assess safety and efficacy of the WiSE (Wireless Stimulation Endocardially) pacing technology in support of U.S. Food and Drug Administration (FDA) approval. The study is expected to randomize 350 heart failure patients in the United States, Europe, and Australia who have failed to respond to, or are otherwise unable to receive, conventional cardiac resynchronization therapy (CRT).
Dr. Walsh, Medical Director of Heart Failure and Cardiac Transplantation at St. Vincent Heart Center in Indianapolis, will join Jagmeet P. Singh, M.D., Ph.D., of Massachusetts General Hospital in Boston to direct this landmark study. Dr. Walsh is a named author of over 100 publications, past president of the American College of Cardiology (ACC), and a former member of the Heart Failure Society of America (HFSA) guidelines committee.
“We are thrilled to have Dr. Walsh take a leadership role on our pivotal study,” said Allan Will, chairman and CEO of EBR Systems. “She is an accomplished leader in the Heart Failure therapy community and a widely recognized clinical researcher. By joining this study she is helping illuminate the under-served population of heart failure patients who have been unable to receive or who have not responded to conventional CRT and risk further deterioration or death.”