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
  Purpose

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.


Condition Intervention Phase
Heart Failure.
Device: Cardiac Resynchronization Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Latin America Cardiac Resynchronization Therapy Study

Resource links provided by NLM:


Further study details as provided by Medtronic Latin America:

Primary Outcome Measures:
  • 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).


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); [ 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);


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Mostly observational study with 1 patient global assessment.
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.

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;
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238874

Locations
Mexico
Hospital Angeles Tijuana
Tijuana, Baja California, Mexico
Hospital Angeles Leon
Leon, Guanajuato, Mexico, OUS
Sponsors and Collaborators
Medtronic Latin America
  More Information

No publications provided

Responsible Party: Hugo Fagioli/Clinical Research Director, Medtronic Latin America
ClinicalTrials.gov Identifier: NCT01238874     History of Changes
Other Study ID Numbers: LA CRT Study
Study First Received: November 9, 2010
Last Updated: March 28, 2011
Health Authority: Food and Drug Administration: Puerto Rico
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Mexico: Secretaria de Salud
Chile: Instituto de Salud Pública de Chile

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014