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First patient enrolled in trial of TAVR in asymptomatic severe aortic stenosis
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The first patient has been recruited in a trial evaluating transcatheter aortic valve replacement in participants with asymptomatic severe aortic stenosis, according to a press release.
The current standard of treatment for these individuals is observation.
“The EARLY TAVR trial is an incredibly important trial for the more than 2.5 million people who suffer from aortic stenosis because it may provide an answer to the frequent dilemma cardiologists face about how they should treat severe aortic stenosis, even though patients have no symptoms,” Philippe Généreux, MD, an interventional cardiologist and co-director of the structural heart program at the Gagnon Cardiovascular Institute at Morristown Medical Center, New Jersey, said in the release. “The progression of aortic stenosis is unpredictable, and there may be a price to pay for waiting to treat — the goal of early intervention with valve replacement is to preserve the heart’s function, prevent further heart deterioration and in some [cases], death.”
EARLY TAVR, funded by Edwards Lifesciences, is a randomized, controlled multicenter trial that will assess TAVR with a balloon-expandable valve (Sapien 3, Edwards) compared with standard clinical surveillance. Participants will be assessed based on a treadmill stress test and followed up for mortality and other parameters.
Disclosure: Généreux reports receiving speaker fees from Cardiovascular Systems, Edwards Lifesciences, Medtronic and Tryton Medical; consultant fees from Boston Scientific, Cardiovascular Systems and Pi-Cardia; an institutional research grant from Boston Scientific; and holding equity in Pi-Cardia, Saranas, SIG.NUM and Soundbite Medical Solutions.