Latin America Cardiac Resynchronization Therapy Study (LatAmCRT)

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure.
• Intervention / Treatment: Device: Cardiac Resynchronization Therapy

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;

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico
      • Hospital Angeles Tijuana
  • Guanajuato
    • Leon, Guanajuato, Mexico, OUS
      • Hospital Angeles Leon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).	Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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);	6 Months

Collaborators and Investigators

• Sponsor: Medtronic Latin America

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: November 9, 2010
• First Submitted That Met QC Criteria: November 9, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LA CRT Study