Abstrakt
The Carmat total artificial heart (C-TAH) is an electro-hydraulically-actuated heart replacement device with biocompatible blood-contacting materials and sensor-based autoregulation. It intends to replace the native heart in patients suffering from end-stage biventricular heart failure.
The device provides fully pulsatile blood flow, adapted to the patient's activities by autoregulation.1 This report summarizes the initial experience with clinical heart transplants from C-TAH implantation within an ongoing European Multicenter Pivotal Study with the primary end-point of 180-day post-implant survival or survival to cardiac transplantation (ClinicalTrials.gov Identifier: NCT02962973). The study was approved by relevant Ethics Committees and Regulatory Authorities.
All patients signed informed consent to participate in the trial.