NCT01238874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Feb 2011

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 29, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

November 9, 2010

Last Update Submit

March 28, 2011

Conditions

Heart Failure.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

No intervention

NO INTERVENTION

Mostly observational study with 1 patient global assessment.

Device: Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization TherapyDEVICE

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

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Angeles Tijuana

Tijuana, Estado de Baja California, Mexico

Location

Hospital Angeles Leon

León, Guanajuato, OUS, Mexico

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2010

First Posted

November 11, 2010

Study Start

February 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

March 29, 2011

Record last verified: 2011-03

Locations

ME(2)