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Article History

Received: 29 June 2020

Accepted: 14 September 2020

First Online: 29 September 2020

Ethics approval and consent to participate

: The design of the study was approved by the “Ethische Commissie Onderzoek UZ/KU Leuven” or the Ethics Committee Research of the University Hospital of Leuven in Belgium (Registration Number S61554), the “London - Riverside Research Ethics Committee” for South London and Maudsley NHS Foundation Trust of The Maudsley Hospital in London – United Kingdom (Reference Number 18/LO/1001), and by the respective ethics committees of all participating centres. To protect the welfare of participants, the study will be approved by the ethics committees at each participating site prior to enrolment of the site’s first patient. The study will be conducted according to the study protocol and in compliance with recognized international standards. Any important protocol modifications and amendments will be immediately communicated to all the participating centres. Prospective participants will receive an explanation of all aspects of the study that is relevant for the participant to make his or her decision, and all participants have to provide a signed informed consent before participating in the study. Participants who provide a signed informed consent but do not satisfy the inclusion criteria will be withdrawn from the study prior to implant and will be considered screen failures; and sites will maintain logs of screening and consenting participants. Participants are informed that they can withdraw their consent at any time without negative consequences for their future care. Participants will be asked if they want to provide a reason for withdrawal. Study physicians can decide to withdraw a participant from the study for urgent medical reasons.

: Not applicable.

: AHY’s independent research is funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London; the views expressed are those of AHY and not necessarily those of the NHS, the NIHR, or the Department of Health. AHY has received fees for lectures and advisory boards from AstraZeneca, Eli Lilly, Lundbeck, Sunovion, Servier, LivaNova, Janssen, Allegan, and Bionomics. AHY is a consultant to Johnson & Johnson and LivaNova. AHY has received honoraria for attending advisory boards and presenting talks at meetings organized by LivaNova.MFJ is funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London; has received speaker honorarium fees and honoraria for attending advisory boards from AstraZeneca, Lundbeck, LivaNova, Janssen, Libbs, Daiichi-Sankyo, and Bionomics; is a consultant to Lundbeck, Johnson & Johnson and LivaNova; and has received honoraria for presenting talks at meetings organized by LivaNova.RDZ is an employee and shareholder of LivaNova.KD has been involved in advisory boards and speaker bureaus with Boehringer Ingelheim, Johnson & Johnson, LivaNova, Lundbeck, Pfizer, and Servier.