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Head-to-Head TAVR 700 Patient Study Comparing the Evolut™ TAVR Platform Against the Edwards SAPIEN Valve in Small Annulus Patients

October 14, 2020

A head-to-head TAVR study in patients with severe symptomatic aortic stenosis (ssAS) has been launched. The news was announced today by Medtronic. The SMall Annuli Randomized To Evolut™ or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic Evolut™ PRO and PRO+TAVR Systems against the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves manufactured by Edwards Lifesciences.

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. Due to its focus on small annulus patients, the SMART Trial will enroll predominantly women, which will provide important clinical insight into a currently 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.

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