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Authors
David, Guy
Epstein, Andrew J.
Giri, Jay
Nathan, Ashwin
Chikermane, Soumya G.
Ryan, Michael
Thompson, Christin
Clancy, Seth
Gunnarsson, Candace https://orcid.org/0000-0003-0723-585X
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Funding
Funding for this research was provided by:
Edwards Lifesciences
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Article History
Received: 21 October 2024
Accepted: 16 January 2025
First Online: 13 February 2025
Declarations
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: The authors report the following disclosures: Guy David, PhD is a consultant for Edwards Lifesciences. Andrew Epstein, PhD is an employee of Medicus Economics, which received funding from Edwards Lifesciences to conduct this research. Jay Giri, MD received research funding and served on advisory boards for Edwards Inc, Recor Medical, Inari Medical, Boston Scientific, and Biosense Webster and has equity in Endovascular Engineering. Ashwin Nathan, MD received speaker fees and institutional research funding from Abiomed, Biosense Webster and Edwards Lifesciences. Soumya G Chikermane, PhD is an employee of Edwards Lifesciences. Michael Ryan, MS is a consultant for Edwards Lifesciences. Christin Thompson, PhD is an employee of Edwards Lifesciences. Seth Clancy, MPH is an employee of Edwards Lifesciences. Candace Gunnarsson, EdD, MA is a consultant for Edwards Lifesciences.
: The WCG IRB determined that this research activity (#1-1709546-1) was exempt from IRB review under 45 CFR ยง46.104(b)(4), because, although the research involves the use of identifiable private information, (1) that information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily by ascertained directly or through identifiers linked to the subjects, (2) the investigator will not contact the subjects, and (3) the investigator will not re-identify subjects. WCG IRB also approved a full waiver of HIPAA authorization for use and disclosure of protected health information (PHI) based on adequate documentation that (1) the use or disclosure of the PHI involves no more than minimal risk to the individuals; (2) the research could not be practicably conducted without access to and use of the PHI; and (3) the research could not practicably be conducted without the waiver. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments.
