Oldenburg, Olaf
Costanzo, Maria Rosa
Germany, Robin
McKane, Scott
Meyer, Timothy E.
Fox, Henrik http://orcid.org/0000-0002-2187-8715
Funding for this research was provided by:
Respcardia (N/A)
Article History
Received: 2 June 2020
Accepted: 15 July 2020
First Online: 12 August 2020
Change Date: 10 November 2021
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s12265-021-10179-9
Compliance with Ethical Standards
:
: The authors have the following conflicts of interest to declare: Fox: no conflict of interest to declare regarding this manuscript. Oldenburg: no conflict of interest to declare regarding this manuscript. Costanzo: was the Primary Investigator for the trial. Germany, McKane and Meyer: Employees of Respicardia.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional ethics committee and with the 1964 Helsinki declaration and its later amendments.
: Written informed consent was obtained from all individual participants included in this study.
: The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and ISO-14155:2011 and registered at ExternalRef removed (Identifier: NCT01816776). All patients provided written informed consent. 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.