Multicenter Automatic Defibrillator Implantation Trial–Subcutaneous Implantable Cardioverter Defibrillator (MADIT S-ICD): Design and clinical protocol - 27/09/17
Doi : 10.1016/j.ahj.2017.04.014
Valentina Kutyifa, MD, PhD a, ⁎ 
, Christopher Beck, PhD b, Mary W. Brown, MS a, David Cannom, MD c, James Daubert, MD d, Mark Estes, MD e, Henry Greenberg, MD f, Ilan Goldenberg, MD g, Stephen Hammes, MD, PhD h, David Huang, MD i, Helmut Klein, MD a, Reinoud Knops, MD, PhD j, Mikhail Kosiborod, MD, PhD k, Jeanne Poole, MD l, Claudio Schuger, MD m, Jagmeet P. Singh, MD, PhD n, Scott Solomon, MD o, David Wilber, MD p, Wojciech Zareba, MD, PhD a, Arthur J. Moss, MD a
, Christopher Beck, PhD b, Mary W. Brown, MS a, David Cannom, MD c, James Daubert, MD d, Mark Estes, MD e, Henry Greenberg, MD f, Ilan Goldenberg, MD g, Stephen Hammes, MD, PhD h, David Huang, MD i, Helmut Klein, MD a, Reinoud Knops, MD, PhD j, Mikhail Kosiborod, MD, PhD k, Jeanne Poole, MD l, Claudio Schuger, MD m, Jagmeet P. Singh, MD, PhD n, Scott Solomon, MD o, David Wilber, MD p, Wojciech Zareba, MD, PhD a, Arthur J. Moss, MD aOn behalf of the MADIT S-ICD Executive Committee
a Heart Research Follow-up Program of the Cardiology Division of the Department of Medicine, University of Rochester Medical Center, Rochester, NY
b Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, NY
c Cardiology Unit of the University of California, Los Angeles, CA
d Division of Cardiology, Duke University, Durham, NC
e Tufts Medical Center, Boston, MA
f Mailman School of Public Health, Columbia University, New York, NY
g Sheba Medical Center, Tel Hashomer, Israel
h Endocrinology Division, University of Rochester Medical Center, Rochester, NY
i Cardiology Division of the Department of Medicine of the University of Rochester Medical Center, Rochester, NY
j Academic Medical Center, Amsterdam, the Netherlands
k St. Luke's Hospital of Kansas City, Kansas City, MO
l University of Washington, Seattle, WA
m Henry Ford Hospital, Detroit, MI
n Massachusetts General Hospital, Boston, MA
o Brigham and Women's Hospital, Boston, MA
p Loyola University Medical Center, Maywood, IL
⁎Reprint requests: Valentina Kutyifa, MD, PhD, Heart Research Follow-up Program, Cardiology Division, University of Rochester Medical Center, 265 Crittenden Blvd, Box 653, Rochester, NY 14642.Heart Research Follow-up Program, Cardiology DivisionUniversity of Rochester Medical Center265 Crittenden Blvd, Box 653RochesterNY14642
Abstract |
Patients with diabetes mellitus, prior myocardial infarction, older age, and a relatively preserved left ventricular ejection fraction remain at risk for sudden cardiac death that is potentially amenable by the subcutaneous implantable cardioverter defibrillator with a good risk-benefit profile. The launched MADIT S-ICD study is designed to test the hypothesis that post–myocardial infarction diabetes patients with relatively preserved ejection fraction of 36%-50% will have a survival benefit from a subcutaneous implantable cardioverter defibrillator.
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| Clinical trial registration: NCT02787785. |
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| Our study has received Food and Drug Administration and Centers for Medicare and Medicaid Services approval in 2016. |
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| Conflict of interest disclosure/acknowledgements: The MADIT S-ICD study is supported by an unrestricted research grant from Boston Scientific Corporation to the University of Rochester Medical Center, Rochester, NY. |
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| Kenneth A. Ellenbogen, MD, served as guest editor for this article. |
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| RCT# NCT02787785 |
© 2017
The Author(s). Publié par Elsevier Masson SAS. Tous droits réservés.
Vol 189
P. 158-166 - juillet 2017 Retour au numéro
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