The MDAC panel recommended a post-approval study that evaluates data such as cardiac outcomes, quality of life, mortality, and functionality. Long term data are also needed to assess complication rates and potential interactions with other implantable devices in the intended patient population. The post-approval study (PAS) protocol has been designed to address these concerns in a real-world setting.
What is the full name of this clinical trial?
OPTIMIZER SMART POST-APPROVAL STUDY