Safety and performance of MR-conditional pacing systems with automated MRI mode at 1.5 and 3 Tesla.

"Declarations GuarantorThe scientific guarantor of this publication is Pr Jean-Nicolas Dacher. Conflict of interestJean-Nicolas Dacher is a member of the European Radiology Editorial Board. He has not taken part in the review or selection process of this article.The following authors of this manuscript declare relationships with the following companies:- Dr. Jean-Nicolas Dacher declares relationship with:• Amicus Therapeutics (consultant and speaker’s fee).• Bayer (speaker’s fee).• General Electric (speaker’s fee).• MicroPort CRM (consultant’s fee).• Takeda (consultant and speaker’s fee).- Dr. Dennis H Lau declares relationship with:• Abbott (speaker’s fee).• Biotronik (speaker’s fee).• Medtronic (speaker’s fee).• MicroPort CRM (consultant’s fee).- Dr. Prenner Günther declares relationship with:• Abbott (speaker’s fee).• Biotronik (speaker’s fee).• Boston (speaker’s fee).- Dr. Maria Emilce Trucco declares relationship with:• Abbott (speaker’s fee).• Biotronik (speaker’s fee).• Boston Scientific (speaker’s fee).• Medtronic (speaker’s fee).• MicroPort CRM (speaker’s fee).The following authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article:- Dr. Patrick Langguth.- Dr. David Adam.- Dr. Walther-Benedikt Winkler.- Dr Julio Martí-Almor.- Dr. Amir Kol.- Dr. Meixiang Xiang.- Dr. Donato Melissano. Statistics and biometryYann Michel, MSc, kindly provided statistical advice for this manuscript. Informed consentWritten informed consent was obtained from all subjects (patients) in this study prior to their inclusion in the trial. Ethical approvalClinical Investigation Plan (CIP) and subject informed consent form were submitted to the Ethics Committee (EC) and all applicable health authorities of the countries where the study was conducted and written approvals were obtained prior to the study start.Below the date of Ethic committee approval for each participating site.CountrySite namePI nameEthic Committee Approval dateAustraliaRoyal Adelaide HospitalPr. Dennis LAU15 Oct 2019—EC approval for site participation in 3 T arm19 Jun 2020—EC approval for site participation in 1.5 T armMonash Medical CentreDr. David Adam05 Dec 2019Nepean HospitalDr. David Coulshed21 Nov 2019Royal Brisbane and women's hospitalDr. Paul Martin19 Dec 2019AustriaLKH, GrazDr. Daniel Scherr22 Nov 2019KH nord, WienaDr. Suzanne Trinks01 Oct 2019Wilhelminenspital, WienDr. Michael NürnbergRudolfstiftung, WienDr. Walter WinklerGermanyMaria Heimsuchung Caritas Klinik Pankow, BerlinDr. Jürgen Meyhöfer20 Dec 2019Evangelisches Klinikum Bethel, BielefeldDr. Carsten Israel20 Dec 2019Universitätsklinikum FreiburgDr. Thomas Faber24 Apr 2020UKSH, KielDr. Demming Thommas13 Jul 2020SpainHospital del Mar, BarcelonaDr. Julio Marti13 Nov 2019Hospital General Universitario de AlicanteDr. Juan Gabriel Martínez16 Jul 2019Alvaro Cunqueiro hospital, VigoDr. Elvis Teijeira16 Jul 2019Hospital Josep Trueta, GironnaDr. Emilce Trucco12 May 2020Hospital Parc Tauli Sabadell, BarcelonaDr. Maria Soledad Ascoeta24 Feb 2021United KingdomSt George's Hospital, LondonDr. Mark Gallagher05 Dec 2019Dorset County HospitalDr. Timothy Edwards21 Feb 2020ItalyOspedale F. Ferrari, CasaranoDr. Donato Melissano24 Feb 2021RIETI—Ospedale San Camillo de LellisDr. Amir KOL16 Oct 2019The NetherlandsIsala ZwolleDr. Delnoy11 Jun 2020ChinaThe Second Affiliated hospital of Zhejiang university school of medicineDr. Meixiang Xiang04 Feb 2021Ningbo hospital of Zhejiang university school of medicineDr. Huimin Chu20 Apr 2021The first Affiliated hospital of Zhejiang university school of medicineDr. Liangrong Zheng13 May 2021 Methodology• prospective.• observational.• multicenter. Conflict of interest Jean-Nicolas Dacher is a member of the European Radiology Editorial Board. He has not taken part in the review or selection process of this article. The following authors of this manuscript declare relationships with the following companies: - Dr. Jean-Nicolas Dacher declares relationship with: • Amicus Therapeutics (consultant and speaker’s fee). • Bayer (speaker’s fee). • General Electric (speaker’s fee). • MicroPort CRM (consultant’s fee). • Takeda (consultant and speaker’s fee). - Dr. Dennis H Lau declares relationship with: • Abbott (speaker’s fee). • Biotronik (speaker’s fee). • Medtronic (speaker’s fee). • MicroPort CRM (consultant’s fee). - Dr. Prenner Günther declares relationship with: • Abbott (speaker’s fee). • Biotronik (speaker’s fee). • Boston (speaker’s fee). - Dr. Maria Emilce Trucco declares relationship with: • Abbott (speaker’s fee). • Biotronik (speaker’s fee). • Boston Scientific (speaker’s fee). • Medtronic (speaker’s fee). • MicroPort CRM (speaker’s fee). The following authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article: - Dr. Patrick Langguth. - Dr. David Adam. - Dr. Walther-Benedikt Winkler. - Dr Julio Martí-Almor. - Dr. Amir Kol. - Dr. Meixiang Xiang. - Dr. Donato Melissano."

"Funding This study has received funding by Microport CRM."