Clinical Registry on Sudden Death Primary Prevention at Latin America

Status Withdrawn

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01422174
Study type	Observational
Source	Biotronik SE & Co. KG
Contact
Status	Withdrawn
Phase	N/A
Start date	March 2012
Completion date	January 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Registry on Sudden Death Primary Prevention at Latin America — ESCAPE-ICD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms