Medtronic (NYSE:MDT) today announced it will begin a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS), primarily in women.

The postmarket SMART trial will compare valve safety and performance of the self-expanding Medtronic Evolut PRO and PRO+TAVR Systems against Edwards Lifesciences’ (NYSE:EW) balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves.

“This head-to-head trial is a new approach for us and has to do with the specifics of this case,” said Michael Coyle, EVP & president of Medtronic’s cardiac and vascular group, during that company’s investor day presentation. “We think there’s a real opportunity to show the supra-annular design’s hemodynamics will translate into short-term hemodynamic benefits and long-term durability benefits. This strategy allows us to highlight to accounts skewed toward Edwards that there are patients who benefit from our supra-annular design. We want to prove that with unambiguous data.”

Enrolling approximately 700 patients globally, the study will evaluate valve performance in patients with small annuli and those who are candidates for TAV-in-SAV procedures (transcatheter valve implanted inside of a failed surgical valve), which combined, represent more than 40% of the global TAVR market, according to Medtronic. Due to its focus on small annulus patients, the SMART trial will enroll predominantly women, which will provide clinical insight into an underrepresented patient population in TAVR literature. The study includes pre-specified endpoints of hemodynamic (blood flow) superiority and clinical non-inferiority with the Evolut platform for mortality, stroke, or rehospitalization at 12 months.

“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. For many of these and other TAVR patients, valve design matters,” said Howard C. Herrmann, M.D., the John Winthrop Bryfogle Professor of Cardiovascular Diseases and director of interventional cardiology in the Perelman School of Medicine at the University of Pennsylvania, and principal investigator and chair of the Steering Committee of the SMART Trial. “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.” Dr. Herrmann has received institutional research funding and financial compensation from Edwards Lifesciences and Medtronic.

The first enrollment in the SMART Trial is targeted for early 2021.

Medtronic Evaluates TAVR in New Patient Populations
Medtronic also announced plans to begin a feasibility study of the Evolut™ TAVR platform to evaluate the self-expanding, supra-annular valve in patients with symptomatic moderate and asymptomatic severe aortic stenosis, new patient populations outside of current guidelines and indications for aortic valve replacement. The Evolut™ EXPAND TAVR I Feasibility Study, which has been submitted to the FDA for Investigational Device Exemption (IDE) approval, would enroll up to 150 patients across both subgroups and evaluate the use of TAVR in patients before signs of left ventricular dysfunction are observed, and will assess the clinical and hemodynamic performance of the Evolut TAVR system to inform future clinical work.

Left untreated, moderate aortic stenosis can be just as deadly for patients as the more severe forms of the disease, according to Dr. Jeffrey Popma, M.D., chief medical officer and VP of medical affairs for the Medtronic’s structural heart business.

“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,” Popma said in a news release. “The outcomes observed from this study will help shape our clinical strategy to pursue expansion of the therapy to new populations who may benefit.”

The company is aiming to benefit as well.

“We’re aggressively investing in TAVR,” Medtronic CEO Geoff Martha told investors.

“Ultimately, we believe Evolut is the best valve choice for the majority of patients,” added Nina Goodheart, president of the company’s structural heart business. “This will translate into share gains in the market.”