Ensure Cardiac Resynchronization Therapy Study

NCT ID: NCT00291564

Last Updated: 2007-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-02-28

Brief Summary

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The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.

Detailed Description

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Conditions

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Heart Failure

Keywords

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Observational Heart Failure Continuous Cardiac Resynchronization Therapy

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Resynchronization Therapy Device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient is indicated for a Medtronic CRT-D system
* Patient is willing to sign Permission for Access to and Use of Health Information form
* Patient is willing and able to comply with follow-up visits through six months

Exclusion Criteria

* Patient has a life expectancy of less than 6 months
* Patient is participating in any concurrent study that could confound the results for either study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Principal Investigators

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David Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

Tennessee Cardiovascular Research Institute

Locations

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Birmingham, Alabama, United States

Site Status

Newport Beach, California, United States

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Trumbull, Connecticut, United States

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Daytona Beach, Florida, United States

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Augusta, Georgia, United States

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Kankakee, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Owensboro, Kentucky, United States

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New Orleans, Louisiana, United States

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Salisbury, Maryland, United States

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Burlington, Massachusetts, United States

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Detroit, Michigan, United States

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Traverse City, Michigan, United States

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Minneapolis, Minnesota, United States

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Mexico, Missouri, United States

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Omaha, Nebraska, United States

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Bridgewater, New Jersey, United States

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Englewood, New Jersey, United States

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Charlotte, North Carolina, United States

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Dayton, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Doylestown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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239

Identifier Type: -

Identifier Source: org_study_id