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

Autor: Jeff S. Healey, Frederick Gadler, Liselot Van Erven, Stuart J. Connolly, Joerg Neuzner, Josef Kautzner, Ursula Appl, Stefan H. Hohnloser, Michael Glikson, Gilles O'Hara, Philippe Mabo, Xavier Viñolas
Přispěvatelé: Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Jazyk: angličtina
Rok vydání: 2012
Předmět:
Tachycardia
medicine.medical_specialty
Defibrillation
medicine.medical_treatment
Electric Countershock
MESH: Electric Countershock
030204 cardiovascular system & hematology
MESH: Epidemiologic Research Design
MESH: Defibrillators
Implantable
law.invention
03 medical and health sciences
0302 clinical medicine
Asia pacific
Randomized controlled trial
[SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system
law
medicine
Humans
030212 general & internal medicine
MESH: Humans
business.industry
Arrhythmias
Cardiac
Implantable cardioverter-defibrillator
medicine.disease
Defibrillators
Implantable
3. Good health
Icd implantation
Surgery
MESH: Arrhythmias
Cardiac
Epidemiologic Research Design
Heart failure
Emergency medicine
[SDV.IB]Life Sciences [q-bio]/Bioengineering
Implant
medicine.symptom
Cardiology and Cardiovascular Medicine
business
Zdroj: American Heart Journal
American Heart Journal, 2012, 164 (2), pp.146-52. ⟨10.1016/j.ahj.2012.05.007⟩
AMERICAN HEART JOURNAL
r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname
American Heart Journal, Elsevier, 2012, 164 (2), pp.146-52. ⟨10.1016/j.ahj.2012.05.007⟩
ISSN: 0002-8703
1097-6744
Popis: 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 ineffective appropriate shock or arrhythmic death. The safety outcome of SIMPLE will include a composite of potentially DT-related procedural complications within 30 days of ICD implantation. Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013. (Am Heart J 2012; 164: 146-52.)
Databáze: OpenAIRE
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