Carlson, Andrew P. http://orcid.org/0000-0003-2189-3699
Slot, Emma M. H.
van Doormaal, Tristan P. C.
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.
,
Funding for this research was provided by:
Polyganics b.v.
Article History
Received: 7 December 2021
Accepted: 21 June 2022
First Online: 20 July 2022
Declarations
:
: This study is performed in accordance with the World Medical Association Declaration of Helsinki [CitationRef removed]; ISO 14155:202011 [CitationRef removed]; the Medical Device Directive (MDD 93/42/EEC and MEDDEV 2.7/3 rev. 3:2015) [CitationRef removed] and MEDDEV 2.7/413 [CitationRef removed]; FDA regulations for IDE studies (G200118/S002) including 21 CFR 50, 54, 56, and 81214; and the Health Insurance Portability and Accountability Act [CitationRef removed]. 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.