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First received: September 14, 2022

Clinical Trial: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Study Status: Completed

Recruit Status: RECRUITING

Condition: Heart Failure

Study Type: INTERVENTIONAL


Official Title: EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Brief Summary: The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device.EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD.The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients.Pediatric candidates with severe isolated left ventricular or…

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