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Clinical Registry on Sudden Death Primary Prevention at Latin America

NCT01422174 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2015-03-03

No results posted yet for this study

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).

Conditions

Interventions

PROCEDURE

Implantable Cardio Defibrillator (ICD),

Standard ICD implantation (as per clinical decision)

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Sergio J Dubner, MD, FACC · Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina

  • William Uribe, MD · CES Cardiología. Medellin, Colombia

  • Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr · Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Argentina

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422174 on ClinicalTrials.gov