With a 25% annual mortality of aortic stenosis patients, you want to perform the procedure as soon as possible after enrolling each patient.
A 2020 study done in Canada showed a median wait time for TAVR patients of 84 days and mortality during the wait was pretty high at 5.7%. There was also a probability of heart failure hospitalization of 7.7% during the wait so doing the procedure ASAP saves lives. I'm pretty sure that our pivotal trial will have a rolling enrollment/implantation.
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