Latin America Cardiac Resynchronization Therapy Study (LatAmCRT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medtronic Latin America
ClinicalTrials.gov Identifier:
NCT01238874
First received: November 9, 2010
Last updated: March 28, 2011
Last verified: March 2011

November 9, 2010
March 28, 2011
February 2011
December 2013   (final data collection date for primary outcome measure)
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo). [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
Same as current
Complete list of historical versions of study NCT01238874 on ClinicalTrials.gov Archive Site
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); [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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);
Same as current
Not Provided
Not Provided
 
Latin America Cardiac Resynchronization Therapy Study
Latin America Cardiac Resynchronization Therapy Study

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;
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure.
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.
No Intervention: No intervention
Mostly observational study with 1 patient global assessment.
Intervention: Device: Cardiac Resynchronization Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2014
December 2013   (final data collection date for primary outcome measure)

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

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01238874
LA CRT Study
Not Provided
Hugo Fagioli/Clinical Research Director, Medtronic Latin America
Medtronic Latin America
Not Provided
Not Provided
Medtronic Latin America
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP