Abbreviations:mm Hg (pressure in millimeters of mercury), NYHA (New York Heart Association), PI (pulmonary valve insufficiency), RV (right ventricle), RVEDD (right ventricular end-diastolic diameter), RVOT (right ventricular outflow tract), SD (standard deviation), VSD (ventricular septal defect), XPV (Xeltis pulmonary valve conduit)
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Funding: This study was funded by an unrestricted research grant from Xeltis B.V. the Netherlands .
Conflicts of interest: Cox, Schutte and Svanidze are employees of, or hold shares/ options in Xeltis. Dr.Carrel is a member of the Advisory Board of Xeltis (without clinical involvement). F.Asch directs an academic cardiovascular imaging core laboratory with institutional contracts to Xeltis (with no personal conflict of interest). All other authors have nothing to disclose.
ClinicalTrials.gov No: NCT02700100
Regulatory approvals: Hungary: Authority: Health Registration and Training Center, Division of Medical Devices
Date: 06 June 2016
Poland: Authority: The Office for Registration of Medicinal Products, medical Devices and Biocidal Products
Date: 20 July 2016
Malaysia: Authority: Medical Device Authority, Ministry of Health Malaysia
Date: 20 Sept 2016