CMS grants IDE to MedStar for trial examining TAVR devices
The Centers for Medicare & Medicaid Services (CMS) granted the Medstar Research Institute an investigational device exemption to conduct a prospective transcatheter aortic valve replacement (TAVR) trial.
The study will assess the safety and feasibility of TAVR in patients who are at least 65 years old, have severe, symptomatic aortic stenosis and are at low risk for surgical aortic valve replacement (SAVR), according to CMS’s July 1 announcement.
Principal investigator Ron Waksman, MD, and colleagues are expected to enroll 200 patients and complete the study by January 2021. They will compare 200 patients who prospectively undergo transfemoral TAVR with a control group of patients who had undergone bioprosthetic SAVR at the same site within the previous 36 months.
The study will take place at MedStar Washington Hospital Center in Washington, D.C. The primary outcomes are 30-day all-cause mortality and the composite of 30-day major adverse events, including stroke, spontaneous MI and life-threatening bleeding.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.