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.