Chang, Stephano J. http://orcid.org/0000-0002-6168-4341
Cajigas, Iahn
Guest, James D.
Noga, Brian R.
Widerström-Noga, Eva
Haq, Ihtsham
Fisher, Letitia
Luca, Corneliu C.
Jagid, Jonathan R.
Funding for this research was provided by:
Boston Scientific Corporation (ISRNMB0018)
Leonard M. Miller School of Medicine, University of Miami (ITS 001003)
Article History
Received: 15 August 2020
Accepted: 21 May 2021
First Online: 2 June 2021
Declarations
:
: The study protocol was approved by the University of Miami Human Subject Research Office (IRB 20190702) and the FDA (IDE G190164). This study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice (GCP) and the applicable regulatory requirements. Trial investigators will obtain written informed consent from each participant before study inclusion. Subjects will be free to withdraw from the study at any time.
: Results from this study will be presented in peer-reviewed publications and meetings without identifying data. Written consent for publication will be obtained from all participants in the study.
: The study is funded in part by Boston Scientific through their Investigator Sponsored Research Award. JJ and CL have consulting agreements with Medtronic Inc., Boston Scientific, Inc., and Abbott Medical. JJ has two funded grants through Medtronic and Boston Scientific. The other authors declare that they have no competing interests.