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Clinical Registry on Sudden Death Primary Prevention at Latin America

Biotronik SE & Co. KG · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria, especially at Latin American countries. OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading primary prevention by the means of clinical evidence on real risk of death in this group of patients. REGISTRY DESIGN: * retrospective (at stage 1); prospective (at stage 2) * multi-center (minimum 25-30 centres) * international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela) * non randomized. * Sample size: at screening about 12.500 patients and 962 patients at treatment stage REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).
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