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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422174
Recruitment Status : Withdrawn (Study stopped due to lost of interest.)
First Posted : August 23, 2011
Last Update Posted : March 3, 2015
Information provided by (Responsible Party):
Biotronik SE & Co. KG

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.


  • 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).

Condition or disease Intervention/treatment
Myocardial Infarction Sudden Death Procedure: Implantable Cardio 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)


  • Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina
  • Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia


• Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain


  • 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Official Title: Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)
Study Start Date : March 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
ICD implantation
Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group
Procedure: Implantable Cardio Defibrillator (ICD),
Standard ICD implantation (as per clinical decision)
Other Name: CE approved devices

Non ICD implantation
Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs)

Primary Outcome Measures :
  1. 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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Latin American countries that fulfill MADIT, MADIT II and/or MUSTT criteria.

Inclusion Criteria:

  • Patients that had Acute Myocardial Infarction (>40 days post-AMI) documented with the presence of Q-wave or cardiac-specific enzymatic markers of myocardial necrosis (CK-MB/troponin), occurred within 3 years previous to enrollment / after June 2008.
  • Left Ventricular Ejection Fraction (LVEF) ≤40% post-revascularization (if no revascularization, measurement performed <3 months previous to patient enrollment, >40 days post-AMI and >3 months post-revascularization -if applicable-).

Exclusion Criteria:

  • Patient with an implanted ICD
  • <18 years old
  • Pregnant or breast feeding women
  • Patients that are already participating in other Investigational Study or Registry
  • Non signed patient informed consent or refusal from patient's reference physician to patient participation
  • Patient inability to comply with protocol (assist to scheduled follow-ups), due to: residence displacement out of center's activity area; unstable geographical situation or at very long distance from the center; unstable medical and/or psychological condition
  • Cardiac transplanted (or in transplant waiting list)
  • Severe Heart Failure (or other co-morbidity: cancer, renal failure, etc.)
  • Life expectancy lower than 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422174

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Centro Privado de Cardiologia
Tucuman, Argentina
Sponsors and Collaborators
Biotronik SE & Co. KG
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Principal Investigator: Sergio J Dubner, MD, FACC Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina
Principal Investigator: William Uribe, MD CES Cardiología. Medellin, Colombia
Study Chair: Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain
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Responsible Party: Biotronik SE & Co. KG Identifier: NCT01422174    
Other Study ID Numbers: TA098
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015
Keywords provided by Biotronik SE & Co. KG:
Primary prevention
Latin America
Sudden death
Myocardial infarction
Ejection Fraction
Additional relevant MeSH terms:
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Myocardial Infarction
Death, Sudden
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases