The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: A randomized, controlled trial of defibrillation testing at the time of defibrillator implantation

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F12%3A00055946" target="_blank" >RIV/00023001:_____/12:00055946 - isvavai.cz</a>
Result on the web
<a href="http://www.sciencedirect.com/science/article/pii/S0002870312003638" target="_blank" >http://www.sciencedirect.com/science/article/pii/S0002870312003638</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ahj.2012.05.007" target="_blank" >10.1016/j.ahj.2012.05.007</a>

Result language
angličtina
Original language name
The rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: A randomized, controlled trial of defibrillation testing at the time of defibrillator implantation
Original language description
Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. The SIMPLE trial will determine if ICD implantation without any DT is noninferior to implantation with DT. Patients will be eligible if they are receiving their first ICD using a Boston Scientific device (Boston Scientific, Natick, MA). Patients will be randomized to DT or no DT at the time of ICD implantation. In the DT arm, physicians will make all reasonable efforts to ensure 1 successful intraoperative defibrillation at 17 J or 2 at 21 J. The first clinical shock in all tachycardia zones will be set to 31 J for all patients. The primary outcome of SIMPLE will be the composite of ineffec
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FA - Cardiovascular diseases including cardio-surgery
OECD FORD branch
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Publication year
2012
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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