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Article History

Received: 10 January 2025

Accepted: 6 October 2025

First Online: 30 October 2025

Declarations

:

: The study protocol has been approved by the local ethics committee (EA 70/21) from the university hospital Giessen and Marburg. The study has been conducted in accordance with the principles set forth in the Helsinki Declaration, and patients will give their informed consent for participation in the research study. A screening and enrollment log will be kept in a secure place only accessible to study personnel. This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov (NCT06291714) on 4 March 2024.

: Not applicable.

: MH has received honoraria for giving lectures from Edwards Lifesciences (Irvine, CA, USA). MH has received honoraria for giving lectures from Baxter (Deerfield, IL, USA).ES received honoraria for lectures and has received institutional research funding for an investigator-initiated trial from Edwards Lifesciences (Irvine, CA, USA). ES has received honoraria from Orion Pharma (Hamburg, Germany).MS is consultant for Edwards Lifesciences and has received institutional research funding for investigator-initiated trials and honoraria for giving lectures from Edwards Lifesciences (Irvine, CA, USA). MS has also received honoraria for giving lectures from AMOMED (Vienna, Austria), and has received honoraria for giving lectures from Orion Pharma (Hamburg, Germany). MS has received honoraria for giving lectures from Philips Medizin Systeme Böblingen (Böblingen, Germany). All other authors declared no conflicts of interests.