Wijnberge, M.
Schenk, J.
Terwindt, L. E.
Mulder, M. P.
Hollmann, M. W.
Vlaar, A. P.
Veelo, D. P.
Geerts, B. F.
Funding for this research was provided by:
Edwards Lifesciences (not applicable)
Article History
Received: 2 May 2019
Accepted: 8 August 2019
First Online: 11 October 2019
Ethics approval and consent to participate
: This study protocol has been approved by the Medical Ethics Committee of the AMC in Amsterdam. The study protocol is in adherence with the Declaration of Helsinki and the guideline of Good Clinical Practice. Informed consent will be obtained by trained researchers the day prior to surgery. A subject screening and enrollment log will be kept on a secure server only accessible to study personnel. This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov (NCT03376347).
: As noted in the study protocol, study participants will consent to having their data and results published anonymously.
: The Department of Anesthesiology of the Academic Medical Center (AMC) received financial support for this project from Edwards Lifesciences. DPV, APV, MW and BFG receive consultancy fees from Edwards Lifesciences.