But notice the p value was quoted as <0.0001, which far exceeds that normally accepted as statistical proof of achieving the primary end point. The study was significantly over powered, they really didn't need that many patients. The FDA normally requireds a p-value of better than 0.05 as the threshold to accept a treatment effect is present.
The p-value of the study typically depends on two things. The size of the treatment effect and the number of patients. If the durAVR is really significantly superior than the currently available devices, then they will need fewer participants because of the size of effect which they can estimate from the current patients who have already been implanted.
However the final number to be enrolled will be something that would have to be discussed with the FDA, along with the primary and secondary study endpoints and trial design.
The recommended standard Valve Academic Research Consortium-2 definitions are here, intended to provide a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI, giving better comparability and interpretability between trials
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