I don’t think they will need to carry out implant using the currently approved devices as the data for these treatments are readily available from the previous trials. Superiority trials are common for drugs and medical devices trials when there are existing approved treatments for the disease in the market. The goal of the trial is to show the investigational device is superior to a control treatment. In a nutshell, the design of the randomised controlled trials will be based on a concise research question/s and null hypothesis (e.g. is DurAVR valve clinically superior than the existing devices in treating AP patients aged between 65 and 74 with …) and gather data from the trial and calculate statistical metrics to test the hypothesis based on an acceptance threshold such as 5% (the chance of making a false positive).
Not advice, DYOR
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