Dr. Mary Norine Walsh joins SOLVE CRT Clinical Study as co-principal investigator. The news was announced today by EBR Systems.
The SOLVE CRT Clinical Study, (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) 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).
About Dr. Mary Noriine Walsh: Dr. Walsh is Medical Director of Heart Failure and Cardiac Transplantation at St. Vincent Heart Center in Indianapolis. She will join Jagmeet P. Singh, M.D., Ph.D., of Massachusetts General Hospital in Boston to direct this landmark study. In addition, 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.
As a co-principal investigator of the study: Allan Will, Chairman and CEO of EBR Systems commented: “We are thrilled to have Dr. Walsh take a leadership role on our pivotal study.” He added, 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.”
“I am so excited to participate in this very important SOLVE CRT study, and join a group of international experts to evaluate and confirm the promising early results of the WiSE CRT System,” said Dr. Walsh. “WISE CRT’s endocardial pacing technology has the potential to play a critical role in improving the lives of heart failure patients who have been unable to receive effective care to date and face progressive worsening of their condition.”