Status:
UNKNOWN
Latin America Cardiac Resynchronization Therapy Study
Lead Sponsor:
Medtronic Latin America
Conditions:
Heart Failure.
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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...
Detailed 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 foc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01238874
Start Date
February 1 2011
End Date
December 1 2014
Last Update
March 29 2011
Active Locations (2)
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1
Hospital Angeles Tijuana
Tijuana, Estado de Baja California, Mexico
2
Hospital Angeles Leon
León, Guanajuato, Mexico, OUS