Ivan Netuka, MD, PhD, Yuriy Pya, MD, Makhabbat Bekbossynova, MD, Peter Ivak, MD, PhD, Miroslav Konarik, MD, Finn Gustafsson, MD, PhD, David M. Smadja, PharmD, PhD, Piet Jansen, MD, PhD, and Christian Latrémouille, MD, PhDd.
From the a Institute for Clinical and Experimental Medicine, Prague, Czech Republic; National Research Cardiac Surgery Center, Nur-Sultan (Astana), Kazakhstan; Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Hopital Europeen Georges-Pompidou, Paris, France; and the Carmat SA, Velizy-Villacoublay Cedex, France.
The Carmat total artificial heart (C-TAH) is an electrohydraulically‒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.
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Initial bridge to transplant experience with a bioprosthetic autoregulated artificial heart