EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

This is a prospective study of subjects implanted with the EXCOR Pediatric VAD supported by the EXCOR Active Driving System and patients recently implanted with EXCOR Pediatric supported on the Ikus Driving Unit as reported in the ACTION Registry database. Children who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric VAD will be included in this study. All patients must meet the indications and contraindication as indicated in the device labelling. There are no known additional indications or contraindications associated with the EXCOR® Active Driving System beyond those already established in the EXCOR® Pediatric VAD labeling. The objective of this study is to evaluate device performance and monitor safety and effectiveness of the Berlin Heart EXCOR® Active Driving System while being used with the approved EXCOR® Pediatric Ventricular Assist Device.