Document is current

Article History

Received: 3 May 2023

Revised: 26 June 2023

Accepted: 28 June 2023

First Online: 12 July 2023

Declarations

:

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The protocol was approved by the following local ethics or institutional review boards: Quorum Review IRB, Western Institutional Review Board, Cleveland Clinic Institutional Review Board, the Cooper Health System Institutional Review Board, University of Pennsylvania Office of Regulatory Affairs, Office of Human Subjects Research Institutional Review Board Johns Hopkins University, Lancaster General Hospital Institutional Review Board, Marshfield Clinic Research Foundation, Methodist Healthcare Institutional Review Board, Schulman IRB, Presbyterian Healthcare Institutional Review Board, Spectrum Health Human Research Protection Program, University of Maryland-Baltimore Institutional Review Board, University of Southern California Health Sciences Campus Institutional Review Board, Washington University St. Louis Institutional Review Board, Henry Ford Health System Research Administration, Christ Hospital Institutional Review Board, Baptist Institutional Review Board, Forsyth Medical Center Institutional Review Board, Edward Hospital & Health Services Institutional Review Board, Komisja Bioetyczna przy Dolnoślaskiej Izbie Lekarskiej, and Vorsitzender Ethikkommission Der Medizinischen Fakultät Der Ruhr-Universität Bochum Sitz Bad Oeynhausen.

: Informed consent was obtained from all individual participants included in the study.

: Dr. Samii has no conflicts of interest. McKane and Meyer are employees of ZOLL Respicardia, Inc. Dr. Shah is a consultant to ZOLL Respicardia, Inc.