WASHINGTON, DC – MedStar Cardiovascular Research Network announced that the first patient who underwent transcatheter aortic valve replacement (TAVR) with the Lotus EdgeTM Aortic Valve System (Boston Scientific, Marlborough, MA) as part of the Low Risk TAVR (LRT) trial was successfully discharged from MedStar Washington Hospital Center the day after the procedure.
The patient was part of the LRT trial’s registry arm, which will enroll 50 patients with severe symptomatic aortic stenosis who have bicuspid aortic valves. These patients will receive the Lotus EdgeTM mechanically expandable valve.
The first the Lotus EdgeTM patient underwent the procedure Sept. 1, 2020, and was discharged the following day.
The 50 patients will be enrolled at five centers.
The LRT trial (NCT02628899) is an investigator-sponsored investigational device exemption study. Ron Waksman, MD, Professor of Medicine at Georgetown University and Associate Director of Cardiology and director of Cardiovascular Research and Advanced Education at the MedStar Heart & Vascular Institute, is the principal investigator. The LRT trial was the first Investigational Device Exemption trial approved by the Food and Drug Administration (FDA) to enroll in the U.S.
This was the first implantation of the Lotus Edge valve in a US TAVR patient with low surgical risk.
This study is one of a series of LRT studies that was initiated nearly 4 years ago. These studies compared TAVR in patients with severe symptomatic tricuspid aortic stenosis who were at low surgical risk to a historical cohort of similar patients who underwent surgical aortic valve replacement (SAVR), examined an anticoagulation regimen with and without warfarin, and included a bicuspid registry with balloon-expandable and self-expanding valves and, now, for the first time, the mechanically expandable valve.
“We are excited to continue this breakthrough investigation in the low-risk group which, by now, exceeds 400 patients and nearly 10 publications,” Dr. Waksman said. “We are grateful for the trust from the FDA and the voluntary work of our investigators pursuing research in this field.”