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Authors
Ali Akbari, Amir
Koch, Christian
Schmidt, Götz
Schmermund, Daniel
Langer, Christine
Edinger, Fabian
Denn, Sara Marie
Markmann, Melanie
Sander, Michael
Habicher, Marit
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Funding
Funding for this research was provided by:
Edwards Lifesciences
Justus-Liebig-Universität Gießen
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Article History
Received: 17 October 2025
Accepted: 10 December 2025
First Online: 22 December 2025
Declarations
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: This clinical trial was conducted in accordance with the principles of the Declaration of Helsinki (2013 revision), ICH–Good Clinical Practice (ICH-GCP) guidelines, and applicable national regulations. Ethics approval and consent to participate: Ethical approval was obtained from the institutional ethics committee (Justus Liebig University ethics committee, Chairperson Prof. Dr. H. Tillmanns) prior to the commencement of the study (Reference AZ170/18) on the 31 st of August 2018. Written informed consent was obtained from all participants at least 1 day before surgery by one member of the study team.
: Not applicable (the manuscript contains no identifiable individual person’s data, images, or videos).
: MH has received honoraria for consulting and for giving lectures from Edwards Lifesciences (Irvine, CA, USA). MH has received honoraria for giving lectures from Baxter (Deerfield, IL, USA). AAA has received honoraria for giving lectures from Edwards Lifesciences (Irvine, CA, USA). MS is consultant for Edwards Lifesciences and has received institutional research funding for investigator-initiated trials and honoraria for giving lectures from Edwards Lifesciences. CK, GS, DS, CL, FE, SD and MM have no conflicts of interests relating to this study.
