Latin America Cardiac Resynchronization Therapy Study

Heart Failure. Clinical Trial

— LatAmCRT  

Official title:

Latin America Cardiac Resynchronization Therapy Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01238874
• Other study ID #: LA CRT Study
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 9, 2010
• Last updated: March 28, 2011
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2011
• Source: Medtronic Latin America
• Contact: n/a
• Is FDA regulated: No
• Health authority: Food and Drug Administration: Puerto RicoColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaMexico: Secretaria de SaludChile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

The Latin America CRT Study is a prospective, multicenter, interventional post-market release study conducted in Latin America. The geography includes Puerto Rico and the Caribbean, Mexico and Central America, and South America.

Description:

The purpose of this study is to provide local evidence regarding Cardiac Resynchronization Therapy (CRT), in both pacing and defibrillation devices across Latin America. The primary objective will focus on changes in left ventricular heart size and function measurements in subjects receiving CRT therapy. The following additional parameters will also be collected:

• Data on referral patterns in Latin America;

• Data on device implant (including delivery system, device information, and lead information);

• Clinical data on subject outcomes and changes (improved, unchanged, or worsened) in heart failure status as assessed by heart failure (HF) hospitalizations, New York Heart Association (NYHA) class, mortality, and Quality of Life (QOL) measured by the Patient Global Assessment;

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria: Implant of new CRT-D or CRT-P device (first-time implant), ACC/AHA/HRS/ESC guidelines for implant, NYHA Class II, III or IV, QRS duration >120 ms, LVEF < 35%, Receiving optimal medical/drug therapy, Able to give written informed consent, Are > 21 years of age, Must be able to return for follow-up visits as required, Are not pregnant or do not plan to get pregnant within the next 6 months, Have no physical limitations to perform Echo studies

Exclusion Criteria: Previous or existing CRT system implanted, Unwilling or unable to comply with specified follow-up schedule, Enrolled or intending to participate in another device study during the course of this study that requires specific treatment or device programming, Medical condition that may limit life expectancy to < 6 months

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure.

Intervention

Device:
• Cardiac Resynchronization Therapy
All market-approved Medtronic CRT-D and CRT-P devices will be used in this study. All eligible devices are commercially released and will be used within their intended use per device labeling. The study may include future market-approved devices as they become commercially available. All market-approved leads may be used in the study. Epicardial leads may be used in the study.

Locations

Country	Name	City	State
Mexico	Hospital Angeles Leon	Leon	Guanajuato
Mexico	Hospital Angeles Tijuana	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Latin America

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).	Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).	6 Months	No
Secondary	referral patterns; Report on device implant; Analyze subject clinical status as it pertains to heart failure (HF) hospitalizations, changes in NYHA class, mortality and QOL (Patient Global Assessment);	referral patterns; Report on device implant; Analyze subject clinical status as it pertains to heart failure (HF) hospitalizations, changes in NYHA class, mortality and QOL (Patient Global Assessment);	6 Months	No