Dhruva, Sanket S. http://orcid.org/0000-0003-0674-2032
Zhang, Shumin
Chen, Jiajing
Noseworthy, Peter A.
Doshi, Amit A.
Agboola, Kolade M.
Herrin, Jeph
Jiang, Guoqian
Yu, Yue
Cafri, Guy
Farr, Kimberly Collison
Mbwana, Mwanatumu S.
Ross, Joseph S. http://orcid.org/0000-0002-9218-3320
Coplan, Paul M.
Drozda, Joseph P. Jr.
Funding for this research was provided by:
U.S. Food and Drug Administration (1U01FD006292-01)
Article History
Received: 20 December 2022
Accepted: 25 January 2023
First Online: 4 February 2023
Declarations
:
: This study was deemed exempt from institutional review board review at Mercy Health and was deemed minimal risk research with a waiver of informed consent at Mayo Clinic.
: Dr. Dhruva reports research funding from the Medical Device Innovation Consortium (MDIC), Arnold Ventures, National Institute for Health Care Management, and Department of Veterans Affairs. Drs. Zhang, Cafri, and Coplan are employees of Johnson & Johnson; the manufacturer of the ThermoCool catheters is Biosense Webster, which is part of the Johnson & Johnson Family of Companies. Dr. Noseworthy receives research funding from National Institutes of Health (NIH), including the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Aging, Agency for Healthcare Research and Quality (AHRQ), FDA, and the American Heart Association. He is a study investigator in an ablation trial sponsored by Medtronic. Dr. Noseworthy and Mayo Clinic are involved in potential equity/royalty relationship with AliveCor. Dr. Herrin receives support from the Centers for Medicare and Medicaid Services to develop quality measures; research support from NIH (1R01CA217889-01A1, 1UM1CA233033-01, and 1UG3AT010669-01), Patient-Centered Outcomes Research Institute, and AHRQ (R01 HS022882-02); and support from Delta Airlines. Dr. Ross receives research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, FDA to establish Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), MDIC, AHRQ (R01HS022882), NHLBI of the NIH (R01HS025164, R01HL144644), and the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International and to establish the Collaboration for Research Integrity and Transparency at Yale; in addition, Dr. Ross is an expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. In the past 36 months, Dr. Drozda has received research support from MDIC, Medtronic, and Johnson & Johnson. His non-dependent son is an employee of Boston Scientific. The remaining authors have nothing to disclose.