Document is current

Article History

Received: 24 April 2024

Accepted: 6 June 2024

First Online: 2 July 2024

Declarations

:

: Harold Nijhuis is a paid consultant for Saluda Medical, and Abbott. Harold Nijhuis has a research grant with Abbott. Willem-Jan Hofsté is a paid consultant for Saluda Medical and Abbott. Philippa Armstrong has received travel grants and speaker fees from Saluda Medical. Johan van de Minkelis is a paid consultant for Saluda Medical. Jan Vesper is a paid consultant for Abbott, Boston Scientific, UniQure, Curonix. Jan Vesper has research grants with Abbott and Boston Scientific and is on the advisory board of Abbott. Ashish Gulve is on the advisory board for Medtronic and Boston Scientific. Ashish Gulve has a research grant with Saluda Medical. Ashish Gulve reports personal fees unrelated to the submitted work from Nevro, Medtronic, Boston Scientific and Mainstay Medical. Jan-Willem Kallewaard is on the advisory board of Saluda Medical, Medtronic, Boston Scientific and Abbott. Jan-Willem Kallewaard has research grants from Boston Scientific, Abbott, Nevro and Saluda Medical. Frank Huygen reports personal fees from Abbott, grants, personal fees from Saluda, personal fees from Boston Scientific, personal fees from Grunenthal, personal fees from Pfizer, outside the submitted work. Serge Nikolic is a paid consultant for Saluda Medical, Nevro, and Stratus Medical. Birte E. Dietz and Dave Mugan are employed by Saluda Medical. There are no other relationships that might lead to a conflict of interest in the current study. All other authors have no conflicts of interest to declare.

: The observational data collection strictly adhered to the ethical principles outlined in the Declaration of Helsinki. In the Netherlands, prospective data collection where people are only subjected to treatment in the context of their medical condition and not treatment in the context of the study falls outside the scope of the Medical Research Involving Human Subjects Act (WMO). Consequently, no ethics committee approval was required for the Dutch centers participating in this noninterventional study, an affirmation was provided by the ethics committee (Amsterdam University Medical Centers, W17_309#17.362). The study is duly registered on the International Clinical Trials Registry Platform (Trial NL7889). In Germany, the study is duly registered as NCT05272137 and in the United Kingdom as ISCRTN27710516 and has been reviewed by the ethics committee in both countries. In accordance with the General Data Protection Regulation (GDPR), written informed consent was sought from all participating patients for the use of their data in the study.