Medtronic has announced two new clinical trials focused on the performance of its Evolut TAVR platform.
The first of those studies, the SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial, will examine how the company’s Evolut Pro and Pro+ systems compare to the Sapien 3 and Sapien 3 Ultra valves from Edwards Lifesciences when treating patients with small annuli.
The head-to-head study, which will include approximately 700 patients, is scheduled to begin in early 2021.
Howard C. Herrmann, MD, a professor of cardiovascular disease in the Perelman School of Medicine at the University of Pennsylvania, will serve as the SMART trial’s principal investigator. He has received “institutional research funding and financial compensation” from both Medtronic and Edwards Lifesciences.
“Hemodynamic performance is particularly important in many patients with aortic stenosis, including those with small annuli, surgical aortic valves needing a TAV-in-SAV procedure, patients with left ventricular dysfunction, and those who are young and most active,” Herrmann said in a statement. “For many of these and other TAVR patients, valve design matters. The outcome of this important head-to-head study will allow heart teams to more selectively tailor clinical decision making to ensure the right valve is selected for the right patient.”
Medtronic also announced a new feasibility study to evaluate the Evolut platform’s effectiveness with new patient populations. The Evolut Expand TAVR 1 Feasibility Study, which the company has submitted to the FDA for investigational device exemption approval, would enroll as many as 150 patients with symptomatic moderate and asymptomatic severe aortic stenosis.
“Moderate aortic stenosis, if left untreated, can be just as deadly for patients as the more severe forms of the disease,” Jeffrey Popma, MD, chief medical officer and vice president of medical affairs for Medtronic's structural heart business said. “Limited clinical research has shown that early intervention may reduce the high rates of mortality often seen in these patients as the disease progresses further down the road. The outcomes observed from in this study will help shape our clinical strategy to pursue expansion of the therapy to new populations who may benefit.”