Back to resultsLatin America Cardiac Resynchronization Therapy Study (LatAmCRT)
Primary Purpose
Heart Failure.
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure.
Eligibility Criteria
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
Sites / Locations
- Hospital Angeles Tijuana
- Hospital Angeles Leon
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
No intervention
Arm Description
Mostly observational study with 1 patient global assessment.
Outcomes
Primary Outcome Measures
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
Secondary Outcome Measures
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);
Full Information
NCT ID
NCT01238874
First Posted
November 9, 2010
Last Updated
March 28, 2011
Sponsor
Medtronic Latin America
1. Study Identification
Unique Protocol Identification Number
NCT01238874
Brief Title
Latin America Cardiac Resynchronization Therapy Study
Acronym
LatAmCRT
Official Title
Latin America Cardiac Resynchronization Therapy Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Latin America
4. Oversight
5. Study Description
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 America, and South America.
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 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;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Mostly observational study with 1 patient global assessment.
Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
Description
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
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);
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Angeles Tijuana
City
Tijuana
State/Province
Baja California
Country
Mexico
Facility Name
Hospital Angeles Leon
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
OUS
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Latin America Cardiac Resynchronization Therapy Study
We'll reach out to this number within 24 hrs