Apologies if this has been already posted, but I just noticed that the details of the EFS are now on clinicaltrials.gov so this is the official info.
15 patients as expected. The trial duration for the primary and secondary endpoints is only 30 days, which is fantastic and fits into the expectation of the pivotal trial starting enrollment early next year. The primary endpoints are successful implantation of the device and no death or stroke within 30 days. Secondary endpoints look at more details.
As expected, the trial will be run by Dr Reardon in Houston, who is very familiar with the DurAVR and ADAPT. Good to see another box being ticked and 15 folks getting the chance to undergo what should be life-changing procedures.
https://clinicaltrials.gov/ct2/show/NCT05712161?term=DurAVR&draw=2&rank=1
EFS details posted to official US government site
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