'Non inferior' and randomised controlled study..........
We only need to demonstrate the result is no worse than the usual care (other valves) which is easier to do and likely require a smaller sample size than proving superiority.
A controlled study means there will be ongoing comparison between the products, which will demonstrate if a difference exists (without designing a study that demonstrates that).
A randomised study is quite robust and adds to the validity of the results.
No, the trial wont happen as soon as many of us would like, however, once it does, it may achieve high quality results quite quickly that may tick the boxes for the FDA approval.
Not advice, just an opinion.
Have a nice day.
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