That's a very good question I don't fully know the answer to but I think that whether the pivotal trial contains different patient inclusion or exclusion factors will definitely play a part.
A couple of obvious examples would be the minimum patient age and whether the patient already has a replacement valve implanted or not. The EFS only accepted patients over 65 years old. The pivotal trial could drop that age to 60 in hopes of being able to find more patients more quickly.
The EFS also excluded any patient with a "pre-existing prosthetic heart valve in any position". If the pivotal includes ViV patients, that criterion would obviously change. The FDA may not want to comingle ViV in the pivotal, though, and require a separate trial for ViV.
Patient safety and informed consent is of the utmost importance to hospital review boards, and liability is important to their legal teams, so a change in inclusion or exclusion requirements likely triggers a review and changes in materials doctors are provided to inform prospective patient of the risks and benefits of being implanted with a trial device and to patient consent forms/waivers that patients sign to take part in trials.
So that would likely need at least some of the hospital review process started again.
You can see the 6 inclusion and 30 exclusion criteria of the EFS trial here:
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