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Authors
Carlson, Andrew P. https://orcid.org/0000-0003-2189-3699
Slot, Emma M. H.
van Doormaal, Tristan P. C.
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Voormolen, E. H. J.
Dankbaar, J. W.
Depauw, P.
Brouwers, B.
Germans, M. R.
Baert, E.
Vandersteene, J.
Freyschlag, C. F.
Freyschlag, J.
Thomé, C.
Zenga, F.
Penner, F.
Abdulazim, A.
Sabel, M.
Rapp, M.
Beez, T.
Zuccarello, M.
Sauvageau, E.
Abdullah, K.
Welch, B.
Langer, D.
Ellis, J.
Dehdashti, A.
VanGompel, J.
Bendok, B.
Chaichana, K.
Liu, J.
Dogan, A.
Lim, M. K.
Hayden, M. G.
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Funding
Funding for this research was provided by:
Polyganics b.v.
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Article History
Received: 7 December 2021
Accepted: 21 June 2022
First Online: 20 July 2022
Declarations
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: This study is performed in accordance with the World Medical Association Declaration of Helsinki []; ISO 14155:202011 []; the Medical Device Directive (MDD 93/42/EEC and MEDDEV 2.7/3 rev. 3:2015) [] and MEDDEV 2.7/413 []; FDA regulations for IDE studies (G200118/S002) including 21 CFR 50, 54, 56, and 81214; and the Health Insurance Portability and Accountability Act []. The protocol was approved by the local ethics committees or institutional review boards of all centers that are currently recruiting: Ethics Committee of Citta’ Della Salute e Della Scienza di Torino #153/2021, University Hospital Zurich #BASEC 2021-00407, Ghent University Hospital #B6702021000353, University Medical Center Utrecht #NL71524.041.19, Institutional Review Board of University of New Mexico #21-173, University of Texas Southwestern #STU-2019-1127, University of Cincinnati #2021-0336, and Oregon Health and Science University #STUDY00023102.Written, informed consent to participate will be obtained from all participants.
: Not applicable.
: TPCvD received a consultancy fee in the design phase of the product from Polyganics BV.EMHS receives a research grant through Polygancis BV.APC received no financial support from Polyganics BV.
