NCT01422174

Clinical Registry on Sudden Death Primary Prevention at Latin America

Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

REGISTRY STAGES 2 stages will be performed: * Stage 1 (Screening): 12500 patients with MI and LVEF\<40% will be evaluated, to know ICD implantation prevalence in such patients at Latin American countries * Stage 2 (Treatment): after patient screening and as per clinical decision, 962 patients will be entered in group 1 and 2 (481 each, 1:1) STEERING COMMITTEE * Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina * Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia CLINICAL ASSESSMENT • Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain REGISTRY DURATION * Patient enrollment period initiation: September 2011 * End of patient enrollment: September 2013 * End of FUs: September 2018 * Registry closure and data analyses: 4Q 2018. REGULATORY CONSIDERATIONS As this is an observational registry, no submission to National Authorities is required.

Conditions

• Myocardial Infarction
• Sudden Death

Interventions

Type	Name	Description
PROCEDURE	Implantable Cardio Defibrillator (ICD),	Standard ICD implantation (as per clinical decision)

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-08-23
• Last updated: 2015-03-03

Locations

1 site across 1 country: Argentina