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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.
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;
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Angeles Tijuana
Tijuana, Estado de Baja California, Mexico
Hospital Angeles Leon
León, Guanajuato, Mexico
Start Date
February 1, 2011
Primary Completion Date
December 1, 2013
Completion Date
December 1, 2014
Last Updated
March 29, 2011
200
ESTIMATED participants
Cardiac Resynchronization Therapy
DEVICE
Lead Sponsor
Medtronic Latin America
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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