Clinical Trial: Clinical Registry on Sudden Death Primary Prevention at Latin America

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Biotronik SE & Co. KG

Current Primary Outcome: Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries [ Time Frame: Patients that suffered from MI in the last 3 years and during the enrollment period ]

Primary Outcome at Stage 1: Determine prevalence of patients with myocardial infarction and high risk of sudden death at Latin America, that fulfill inclusion criteria

Primary Outcome at Stage 2: Compare MACE development in patients that receive ICD implantation vs patients that receive other type of treatment (non ICD)



Original Primary Outcome: Same as current

Current Secondary Outcome: Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring [ Time Frame: 5 years (until end 2018) ]

Original Secondary Outcome: Same as current

Information By: Biotronik SE & Co. KG

Dates:
Date Received: August 18, 2011
Date Started: March 2012
Date Completion: January 2015
Last Updated: March 2, 2015
Last Verified: March 2015