Funding for this research was provided by:
Received: 13 August 2019
Accepted: 20 January 2020
First Online: 31 January 2020
Ethics approval and consent to participate
: The study will be conducted according to the principles of the Declaration of Helsinki (version of 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations and Acts. Patients will provide written informed consent. Ethics approval for the primary protocol and the two subsequent substantial amendments was provided by the Amsterdam UMC, location AMC, medical ethics committee, Amsterdam, the Netherlands. Study monitoring will be performed in accordance with the ICH GCP guidelines by an independent monitor according to a monitor plan with visits prior to inclusion of the first patient, at predetermined moments during the study and after the last visit of the final patient.
: Not applicable.
: JD: unconditional supplementary grants were supplied by Medtronic for the primary 1-year follow-up of the INVEST study and for the extended 3-year follow-up. The other authors have no competing interests.