Kouz, Karim http://orcid.org/0000-0001-8107-6952
Bergholz, Alina http://orcid.org/0000-0001-8240-3812
Diener, Oliver
Leistenschneider, Maximilian
Thompson, Christina
Pichotka, Friederike
Trepte, Constantin http://orcid.org/0000-0001-5791-3212
Schwedhelm, Edzard http://orcid.org/0000-0003-3597-6276
Renné, Thomas http://orcid.org/0000-0003-4594-5975
Krause, Linda http://orcid.org/0000-0002-8490-5717
Nicklas, Julia Y.
Saugel, Bernd http://orcid.org/0000-0001-6619-0722
Funding for this research was provided by:
Universitätsklinikum Hamburg-Eppendorf (UKE)
Article History
Received: 13 December 2021
Accepted: 31 January 2022
First Online: 24 February 2022
Declarations
:
: KK is a consultant for Edwards Lifesciences Inc. (Irvine, CA, USA) and Vygon (Aachen, Germany). AB, OD, ML, CTh, FP, CT, LK, ES, and TR have no conflict of interest to declare. JYN has received refunds of travel expenses from CNSystems Medizintechnik GmbH (Graz, Austria). BS is a consultant for and has received honoraria for giving lectures from Edwards Lifesciences Inc. (Irvine, CA, USA). BS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from Pulsion Medical Systems SE (Feldkirchen, Germany). BS has received institutional restricted research grants and honoraria for giving lectures from CNSystems Medizintechnik GmbH (Graz, Austria). BS is a consultant for and has received honoraria for giving lectures from Philips Medizin Systeme Böblingen GmbH (Böblingen, Germany). BS is a consultant for and has received institutional restricted research grants and honoraria for giving lectures from GE Healthcare (Chicago, IL, USA). BS is a consultant for and has received honoraria for giving lectures from Vygon (Aachen, Germany). BS is a consultant for and has received honoraria for giving lectures from Baxter (Deerfield, IL, USA). BS is a consultant for and has received institutional restricted research grants from Retia Medical LLC (Valhalla, NY, USA). BS has received institutional restricted research grants from Osypka Medical (Berlin, Germany). BS was a consultant for and has received institutional restricted research grants from Tensys Medical Inc. (San Diego, CA, USA).
: The original trial and the present study were approved by the ethics committee (Ethikkomission der Ärztekammer Hamburg, Hamburg, Germany; chair: Prof. Dr. Rolf Stahl, registration number PV5018) on 4 August 2015 and 2 December 2020.
: Written informed consent was obtained from all individual participants included in the study.
: Not applicable.