Validation of CardioMEMS HF System Cardiac Output Algorithm IDE Clinical Investigation Plan

There are two primary objectives of this clinical investigation. The first objective is to finalize development of the algorithm estimating CO by collecting paired cMRI measurements of CO, as well as other parameters of heart function, and CardioMEMS HF System readings in the same subject. The second objective of this clinical investigation is to use data collected during the validation phase, distinct from the subjects within the development phase, to evaluate the agreement between the CardioMEMS HF System-derived CO and the CO values from cMRI in patients previously implanted with the commercially available CardioMEMS HF System.